MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for FIXODENTDENTURECAREDENTUREADHESIVEFOODSEALCRMFRESH manufactured by Proctor & Gamble Manufacturing Co..
[46332580]
Product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[46332581]
Angioedema [angioedema] anaphylaxis [anaphylactic reaction] tongue - swelling [swollen tongue] swelling - face, jaw swelling [swelling face] swelling - lips [lip swelling] redness [erythema]. Case description: an (b)(6) female consumer reported that she used fixodent denture care denture adhesive food seal cream fresh, fixodent denture care denture adhesive free cream neutral (41994), and fixodent denture adhesive, version unknown beginning on an unspecified date in (b)(6)-2011, using a very small amount only when she went somewhere. She reported that when she used the fixodent and other unspecified denture adhesive brands, she experienced a lot of swelling in her lips and face about an hour after applying the adhesive and inserting the dentures; she even tried the zinc free version and the same thing happened. She went to the hospital (emergency room) once and to her doctor quite a few times where she was given injections. She self treated her symptoms using ice bags. She stopped using the product "months ago" and her symptoms resolved a couple of days later. She stated that this had been happening for a long time now, as she wasn't sure what was causing it; she asserted that she was now unable to wear her teeth. The case outcome was recovered. No further information was provided. On 27-apr-2016 received consumer's adverse event questionnaire: the consumer stated that she used the fixodent occasionally as directed to secure her dentures. She first used the product in (b)(6)-2011 to secure her dentures (starting use at the time she got her dentures), and stated that product use was ongoing when using with her dentures on occasion. One day after using the product, she experienced lips, face/jaw, and tongue swelling. She experienced this in (b)(6)-2011, and was experiencing it now: on these occasions, she treated her symptoms with benadryl. From (b)(6) 2012 she reported that she was hospitalized as a result of these symptoms. She sought the advice of a medical professional by telephoning her physician. Additionally, she visited her physician, the emergency room, and was hospitalized on the aforementioned dates. Treatment prescribed/recommended by the health care professional included an intravenous line with anti-allergic medicines, x-rays, computed tomography scans, and allergy testing; additionally, she was prescribed an epi-pen and it was suggested that she not use the product or wear her false teeth. She described that the prescribed/recommended treatment was followed and her problem had been resolved until she used the product again. She explained that in the past she used the product when wearing her dentures to secure them, and each time caused swelling, redness, and on occasion two hospital visits for angioedema. She stated that now she must use benadryl each time she used her dentures, which she explained was only when she went out in public (once per month). She stated that she did not have any allergies. Concomitant medications included: atorvastatin/lipitor 20mg daily for cholesterol, oxybutynin 5mg daily for bladder control, sertraline dcl/zoloft 100mg daily for depression, and levothyroxine/levoxyl 75mg daily for thyroid. The case outcome was now unknown. No further information was provided. On 27-apr-2016 received medicare summary notice: the consumer was seen for an office/outpatient visit on (b)(6) 2012 and received a heterophile antibody screen and strep a assay with optic. On (b)(6) 2011, (b)(6) 2012, and (b)(6) 2013 she also was seen for an office/outpatient visit. She was seen for an office/outpatient visit as well on (b)(6) 2011 where she received medroxyprogesterone acetate and triamcinolone acetate injections; she also received two other unspecified therapeutic/prophylactic/diagnostic injections. On (b)(6) 2012, she had an emergency department visit where a 12-lead electrocardiogram and unspecified radiology services were performed. She also had an emergency department visit on (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received description of services bill, dated (b)(6) 2012: the consumer underwent unspecified radiology services on (b)(6) 2012. The case outcome was unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet and receipt, dated (b)(6) 2012: the consumer was seen as a new patient. Issues included: angioneurotic edema, urticaria idiopathic. Her next appointment was scheduled for (b)(6) 2012. The case outcome was unknown. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant), ch 50 (total), antinuclear antibody (ana), thyroid peroxidase ab, and thyroglobulin antibody testing and the diagnosis was angioedema. The case outcome was unknown. No further information was provided. On 27-apr-2016 received medication list, dated (b)(6) 2012: the consumer was directed to take omeprazole, 40mg check in the morning, 30-40 minutes before breakfast or after dinner; allegra 180mg check in the morning; zyrtec check at bedtime. She was also instructed to keep a food diary and to get blood done if she had any episodes of swelling within 4 hours. She was also told to implement a diet change that included avoiding spicy foods, caffeine, and soda. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant) testing and the diagnosis was anaphylaxis (unknown) and angioedema. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet, dated (b)(6) 2012: the consumer was seen for an office visit routine on (b)(6) 2012 and had a percutaneous allergy test. Other issues included: rhinitis-chronic, angioneurotic edema, and gastroesophageal reflux disease/post nasal drip. Her next appointment was scheduled for (b)(6) 2012. The case outcome remained unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[47937948]
On 10-jun-2016 product investigation results: product returned by reporter on 25-may-2016. Product investigation revealed: manufactured as intended based on investigation.
Patient Sequence No: 1, Text Type: N, H10
[47937949]
Angiodema [angioedema]. Anaphylaxis [anaphylactic reaction]. Tongue - swelling [swollen tongue]. Swelling - face, jaw swelling [swelling face]. Swelling - lips [lip swelling]. Redness [erythema]. Case description: an (b)(6) female consumer reported that she used fixodent denture care denture adhesive food seal cream fresh, fixodent denture care denture adhesive free cream neutral (41994), and fixodent denture adhesive, version unknown beginning on an unspecified date in (b)(6) 2011, using a very small amount only when she went somewhere. She reported that when she used the fixodent and other unspecified denture adhesive brands, she experienced a lot of swelling in her lips and face about an hour after applying the adhesive and inserting the dentures; she even tried the zinc free version and the same thing happened. She went to the hospital (emergency room) once and to her doctor quite a few times where she was given injections. She self treated her symptoms using ice bags. She stopped using the product "months ago" and her symptoms resolved a couple of days later. She stated that this had been happening for a long time now, as she wasn't sure what was causing it; she asserted that she was now unable to wear her teeth. The case outcome was recovered. No further information was provided. On 27-apr-2016 received consumer's adverse event questionnaire: the consumer stated that she used the fixodent occasionally as directed to secure her dentures. She first used the product in (b)(6) 2011 to secure her dentures (starting use at the time she got her dentures), and stated that product use was ongoing when using with her dentures on occasion. One day after using the product, she experienced lips, face/jaw, and tongue swelling. She experienced this in (b)(6) 2011, and was experiencing it now: on these occasions, she treated her symptoms with benadryl. From (b)(6) 2012 she reported that she was hospitalized as a result of these symptoms. She sought the advice of a medical professional by telephoning her physician. Additionally, she visited her physician, the emergency room, and was hospitalized on the aforementioned dates. Treatment prescribed/recommended by the health care professional included an intravenous line with anti-allergic medicines, x-rays, computed tomography scans, and allergy testing; additionally, she was prescribed an epi-pen and it was suggested that she not use the product or wear her false teeth. She described that the prescribed/recommended treatment was followed and her problem had been resolved until she used the product again. She explained that in the past she used the product when wearing her dentures to secure them, and each time caused swelling, redness, and on occasion two hospital visits for angioedema. She stated that now she must use benadryl each time she used her dentures, which she explained was only when she went out in public (once per month). She stated that she did not have any allergies. Concomitant medications included: atorvastatin/lipitor 20mg daily for cholesterol, oxybutynin 5mg daily for bladder control, sertraline dcl/zoloft 100mg daily for depression, and levothyroxine/levoxyl 75mg daily for thyroid. The case outcome was now unknown. No further information was provided. On 27-apr-2016 received (b)(6) summary notice: the consumer was seen for an office/outpatient visit on (b)(6) 2012 and received a heterophile antibody screen and strep a assay with optic. On (b)(6) 2011, (b)(6) 2012, and (b)(6) 2013 she also was seen for an office/outpatient visit. She was seen for an office/outpatient visit as well on (b)(6) 2011 where she received medroxyprogesterone acetate and triamcinolone acetate injections; she also received two other unspecified therapeutic/prophylactic/diagnostic injections. On (b)(6) 2012, she had an emergency department visit where a 12-lead electrocardiogram and unspecified radiology services were performed. She also had an emergency department visit on (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received description of services bill, dated (b)(6) 2012: the consumer underwent unspecified radiology services on (b)(6) 2012. The case outcome was unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet and receipt, dated (b)(6) 2012: the consumer was seen as a new patient. Issues included: angioneurotic edema, urticaria idiopathic. Her next appointment was scheduled for (b)(6) 2012. The case outcome was unknown. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant), ch 50 (total), antinuclear antibody (ana), thyroid peroxidase ab, and thyroglobulin antibody testing and the diagnosis was angioedema. The case outcome was unknown. No further information was provided. On 27-apr-2016 received medication list, dated (b)(6) 2012: the consumer was directed to take omeprazole, 40mg check in the morning, 30-40 minutes before breakfast or after dinner; allegra 180mg check in the morning; zyrtec check at bedtime. She was also instructed to keep a food diary and to get blood done if she had any episodes of swelling within 4 hours. She was also told to implement a diet change that included avoiding spicy foods, caffeine, and soda. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant) testing and the diagnosis was anaphylaxis (unknown) and angioedema. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet, dated (b)(6) 2012: the consumer was seen for an office visit routine on (b)(6) 2012 and had a percutaneous allergy test. Other issues included: rhinitis-chronic, angioneurotic edema, and gastroesophageal reflux disease/post nasal drip. Her next appointment was scheduled for (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 10-jun-2016 product investigation results: the consumer returned one 90% empty tube of fixodent plus scope food seal 2 ounce with lot 30404 on 25-may-2016. Batch manufacturing check finds: no related complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 9 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. The product expired on 09-feb-2016, we do not test expired product; there is not an expiration date for this product in the united states, however in (b)(6) the expiration date is 3 years from the date the product is made. We don't intend for consumer to use product past the expiration date and cannot complete an investigation of expired product; this complaint will not be investigated any further. Based on the information given and the batch records, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 13-jun-2016 product investigation results: consumer returned one 90% empty tube of fixodent no zinc added neutral 2. 4 ounce with lot 41994 without the carton on 25-may-2016. Batch manufacturing check finds: no other complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 2 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. A sample from retain box # (b)(4) was sent for full finished product testing of representative retain sample. The results were passing for all tests performed. Based on the information given, the batch records and the retain sample testing, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 16-jun-2016 received consumer follow-up: the consumer called on (b)(6) 2016 and stated that she was no longer using the fixodent and had not been to the doctor, either. She was not having any more symptoms since she stopped using the fixodent, and had not received any further treatment. The case outcome was recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[51491764]
On 10-jun-2016 product investigation results: product returned by reporter on 25-may-2016. Product investigation revealed: manufactured as intended based on investigation.
Patient Sequence No: 1, Text Type: N, H10
[51491805]
Angioedema [angioedema], anaphylaxis [anaphylactic reaction], tongue - swelling [swollen tongue], swelling - face, jaw swelling [swelling face], swelling - lips [lip swelling], redness [erythema]. Case description: an (b)(6) female consumer reported that she used fixodent denture care denture adhesive food seal cream fresh, fixodent denture care denture adhesive free cream neutral (41994), and fixodent denture adhesive, version unknown beginning on an unspecified date in (b)(6) 2011, using a very small amount only when she went somewhere. She reported that when she used the fixodent and other unspecified denture adhesive brands, she experienced a lot of swelling in her lips and face about an hour after applying the adhesive and inserting the dentures; she even tried the zinc free version and the same thing happened. She went to the hospital (emergency room) once and to her doctor quite a few times where she was given injections. She self treated her symptoms using ice bags. She stopped using the product "months ago" and her symptoms resolved a couple of days later. She stated that this had been happening for a long time now, as she wasn't sure what was causing it; she asserted that she was now unable to wear her teeth. The case outcome was recovered. No further information was provided. On 27-apr-2016 received consumer's adverse event questionnaire: the consumer stated that she used the fixodent occasionally as directed to secure her dentures. She first used the product in (b)(6) 2011 to secure her dentures (starting use at the time she got her dentures), and stated that product use was ongoing when using with her dentures on occasion. One day after using the product, she experienced lips, face/jaw, and tongue swelling. She experienced this in (b)(6) 2011, and was experiencing it now: on these occasions, she treated her symptoms with benadryl. From (b)(6) 2012 she reported that she was hospitalized as a result of these symptoms. She sought the advice of a medical professional by telephoning her physician. Additionally, she visited her physician, the emergency room, and was hospitalized on the aforementioned dates. Treatment prescribed/recommended by the health care professional included an intravenous line with anti-allergic medicines, x-rays, computed tomography scans, and allergy testing; additionally, she was prescribed an epi-pen and it was suggested that she not use the product or wear her false teeth. She described that the prescribed/recommended treatment was followed and her problem had been resolved until she used the product again. She explained that in the past she used the product when wearing her dentures to secure them, and each time caused swelling, redness, and on occasion two hospital visits for angioedema. She stated that now she must use benadryl each time she used her dentures, which she explained was only when she went out in public (once per month). She stated that she did not have any allergies. Concomitant medications included: atorvastatin/lipitor 20mg daily for cholesterol, oxybutynin 5mg daily for bladder control, sertraline dcl/zoloft 100mg daily for depression, and levothyroxine/levoxyl 75mg daily for thyroid. The case outcome was now unknown. No further information was provided. On 27-apr-2016 received medicare summary notice: the consumer was seen for an office/outpatient visit on (b)(6) 2012 and received a heterophile antibody screen and strep a assay with optic. On (b)(6) 2011, (b)(6) 2012, and (b)(6) 2013 she also was seen for an office/outpatient visit. She was seen for an office/outpatient visit as well on (b)(6) 2011 where she received medroxyprogesterone acetate and triamcinolone acetate injections; she also received two other unspecified therapeutic/prophylactic/diagnostic injections. On (b)(6) 2012, she had an emergency department visit where a 12-lead electrocardiogram and unspecified radiology services were performed. She also had an emergency department visit on (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received description of services bill, dated (b)(6) 2012: the consumer underwent unspecified radiology services on (b)(6) 2012. The case outcome was unknown. No further information was provided. 2on 7-apr-2016 received allergy test discharge sheet and receipt, dated (b)(6) 2012: the consumer was seen as a new patient. Issues included: angioneurotic edema, urticaria idiopathic. Her next appointment was scheduled for (b)(6) 2012. The case outcome was unknown. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant), ch 50 (total), antinuclear antibody (ana), thyroid peroxidase ab, and thyroglobulin antibody testing and the diagnosis was angioedema. The case outcome was unknown. No further information was provided. On 27-apr-2016 received medication list, dated (b)(6) 2012: the consumer was directed to take omeprazole, 40mg check in the morning, 30-40 minutes before breakfast or after dinner; allegra 180mg check in the morning; zyrtec check at bedtime. She was also instructed to keep a food diary and to get blood done if she had any episodes of swelling within 4 hours. She was also told to implement a diet change that included avoiding spicy foods, caffeine, and soda. No further information was provided. On 27-apr-2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor,functional, c-4, c1q (complement quant) testing and the diagnosis was anaphylaxis (unknown) and angioedema. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet, dated (b)(6) 2012: the consumer was seen for an office visit routine on (b)(6) 2012 and had a percutaneous allergy test. Other issues included: rhinitis-chronic, angioneurotic edema, and gastroesophageal reflux disease/post nasal drip. Her next appointment was scheduled for (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 10-jun-2016 product investigation results: the consumer returned one 90% empty tube of fixodent plus scope food seal 2 ounce with lot 30404 on 25-may-2016. Batch manufacturing check finds: no related complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 9 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. The product expired on 09-feb-2016, we do not test expired product; there is not an expiration date for this product in the united states, however in canada the expiration date is 3 years from the date the product is made. We don't intend for consumer to use product past the expiration date and cannot complete an investigation of expired product; this complaint will not be investigated any further. Based on the information given and the batch records, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 13-jun-2016 product investigation results: consumer returned one 90% empty tube of fixodent no zinc added neutral 2. 4 ounce with lot 41994 without the carton on 25-may-2016. Batch manufacturing check finds: no other complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 2 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. A sample from retain box # fp14-032 was sent for full finished product testing of representative retain sample. The results were passing for all tests performed. Based on the information given, the batch records and the retain sample testing, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 16-jun-2016 received consumer follow-up: the consumer called on 16-jun-2016 and stated that she was no longer using the fixodent and had not been to the doctor, either. She was not having any more symptoms since she stopped using the fixodent, and had not received any further treatment. The case outcome was recovered. No further information was provided. On 25-jul-2016 received consumer's medical bills: medical bill dated (b)(6) 2012: the consumer was admitted on (b)(6) 2012 and discharged on (b)(6) 2012. Patient type: inpatient. On (b)(6) 2012, she received pepcid, solu-medrol, klor-con 10, and benadryl. On (b)(6) 2012, she received pepcid premixed, tylenol, and ambien. She underwent a comprehensive metabolic panel, trypsin (serum), complete blood count with differential panel, urine culture, urinalysis screen, urine microscopic, pulse oximetry (multiple), and a 12 lead electrocardiogram on (b)(6) 2012. On (b)(6) 2012 she underwent testing of her potassium level. Results were unknown. Medical bill dated (b)(6) 2014: the consumer was admitted on (b)(6) 2014 and discharged on (b)(6) 2014. Patient type: outpatient. On (b)(6) 2014 she underwent a comprehensive metabolic panel, thyroid stimulating hormone - 3rd generation, thyroxine (free), lipid panel, complete blood count with differential panel. Results were unknown. Medical bill dated 16-apr-2014: the consumer was admitted on (b)(6) 2014 and discharged on (b)(6) 2014. Patient type: emergency room. On (b)(6) 2014 she received toradol, reglan, and lorcet-5. She underwent a urine drug screen, comprehensive metabolic panel, thyroid stimulating hormone - 3rd generation, thyroxine (free), complete blood count with differential panel, sedimentation rate, urine culture, urinalysis screen with reflex culture, urinalysis microscopic, computed tomography head without contrast, and computed tomography sinuses without contrast on (b)(6) 2014. Results were unknown. Medical bill dated 19-nov-2014: the consumer was admitted on (b)(6) 2014 and discharged on (b)(6) 2014. Patient type: outpatient. On (b)(6) 2014 she underwent a comprehensive metabolic panel, thyroid stimulating hormone - 3rd generation, thyroxine (free), vitamin b-12 (serum), lipid panel, vitamin d, 1, 25-dihydroxyvitamin, and complete blood count without differential panel. Results were unknown. Medical bill dated 20-may-2015: the consumer was admitted on (b)(6) 2015 and discharged on (b)(6) 2015. Patient type: outpatient. On (b)(6) 2015 she underwent a comprehensive metabolic panel, thyroxine (free), vitamin b-12 (serum), lipid panel, testosterone, vitamin d 25-hydroxy, and complete blood count without differential panel. Results were unknown. Medical bill dated 15-nov-2015: the consumer was admitted on (b)(6) 2015 and discharged on (b)(6) 2015. Patient type: outpatient. On (b)(6) 2015, she underwent a comprehensive metabolic panel, thyroid stimulating hormone - 3rd generation, thyroxine (free), lipid panel, vitamin d 25-hydroxy, complete blood count without differential panel. Results were unknown. The case outcome remained recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[57605335]
On 10-jun-2016 product investigation results: product returned by reporter on 25-may-2016. Product investigation revealed: manufactured as intended based on investigation.
Patient Sequence No: 1, Text Type: N, H10
[57605336]
Angioedema / discharge diagnosis: angioedema, secondary to (allergic reaction) / angioedema, most likely reaction to her new denture paste [angioedema]. Anaphylaxis [anaphylactic reaction]. Tongue - swelling / swelling of left tongue / because of the swelling of the tongue, she was having difficulty speaking [swollen tongue]. Swelling - face, jaw swelling / complains of local facial swelling [swelling face]. Swelling - lips / moderate swelling of lower lip [lip swelling]. Redness [erythema]. Nausea [nausea]. Dizzy / lightheadedness / feeling she may pass out [dizziness]. Respiratory distress [respiratory distress]. Discharge diagnosis: (angioedema) secondary to allergic reaction [hypersensitivity]. Swelling of throat / developed mild sense of swelling in the back of the throat [pharyngeal oedema]. Trouble breathing secondary to (angioedema) / shortness of breath [dyspnoea]. Lower mouth swells up / developed mild sense of swelling in the back of the (throat) and mouth [mouth swelling]. Irritation of the throat [throat irritation]. Blood pressure systolic elevated [blood pressure systolic increased]. Respiratory rate elevated [respiratory rate increased]. Diastolic blood pressure depressed [blood pressure diastolic decreased]. Sensation of throat closing [choking sensation]. Facial edema [face oedema]. Non-pruritic rash [rash]. Acute allergic dermatitis [dermatitis allergic]. Dermatitis [dermatitis]. Tachycardia [tachycardia]. Palpitations, most likely (anxiety) related / heart was racing [palpitations]. (palpitations), most likely anxiety related [anxiety]. (palpitations) with presyncope/near-syncope [presyncope]. Diaphoretic [hyperhidrosis]. Edema underneath her tongue and difficulty speaking/large amount of sublingual edema [tongue oedema]. Case description: an (b)(6) year old female consumer reported that she used fixodent denture care denture adhesive food seal cream fresh, fixodent denture care denture adhesive free cream neutral (41994), and fixodent denture adhesive, version unknown beginning on an unspecified date in (b)(6) 2011, using a very small amount only when she went somewhere. She reported that when she used the fixodent and other unspecified denture adhesive brands, she experienced a lot of swelling in her lips and face about an hour after applying the adhesive and inserting the dentures; she even tried the zinc free version and the same thing happened. She went to the hospital (emergency room) once and to her doctor quite a few times where she was given injections. She self treated her symptoms using ice bags. She stopped using the product "months ago" and her symptoms resolved a couple of days later. She stated that this had been happening for a long time now, as she wasn't sure what was causing it; she asserted that she was now unable to wear her teeth. The case outcome was recovered. No further information was provided. On 27-apr-2016 received consumer's adverse event questionnaire: the consumer stated that she used the fixodent occasionally as directed to secure her dentures. She first used the product in (b)(6) 2011 to secure her dentures (starting use at the time she got her dentures), and stated that product use was ongoing when using with her dentures on occasion. One day after using the product, she experienced lips, face/jaw, and tongue swelling. She experienced this in (b)(6) 2011, and was experiencing it now: on these occasions, she treated her symptoms with (b)(4). From (b)(6) 2012 she reported that she was hospitalized as a result of these symptoms. She sought the advice of a medical professional by telephoning her physician. Additionally, she visited her physician, the emergency room, and was hospitalized on the aforementioned dates. Treatment prescribed/recommended by the health care professional included an intravenous line with anti-allergic medicines, x-rays, computed tomography scans, and allergy testing; additionally, she was prescribed an epi-pen and it was suggested that she not use the product or wear her false teeth. She described that the prescribed/recommended treatment was followed and her problem had been resolved until she used the product again. She explained that in the past she used the product when wearing her dentures to secure them, and each time caused swelling, redness, and on occasion two hospital visits for angioedema. She stated that now she must use benadryl each time she used her dentures, which she explained was only when she went out in public (once per month). She stated that she did not have any allergies. Concomitant medications included: atorvastatin/lipitor 20mg daily for cholesterol, oxybutynin 5mg daily for bladder control, sertraline dcl/zoloft 100mg daily for depression, and levothyroxine/levoxyl 75mg daily for thyroid. The case outcome was now unknown. No further information was provided. On 27-apr-2016 received medicare summary notice: the consumer was seen for an office/outpatient visit on (b)(6) 2012 and received a heterophile antibody screen and strep assay with optic. On (b)(6) 2011, 16-jan-2012, (b)(6) 2012, and (b)(6) 2013 she also was seen for an office/outpatient visit. She was seen for an office/outpatient visit as well on (b)(6) 2011 where she received medroxyprogesterone acetate and triamcinolone acetate injections; she also received two other unspecified therapeutic/prophylactic/diagnostic injections. On (b)(6) 2012, she had an emergency department visit where a 12-lead electrocardiogram and unspecified radiology services were performed. She also had an emergency department visit on (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received description of services bill, dated (b)(6) 2012: the consumer underwent unspecified radiology services on (b)(6) 2012. The case outcome was unknown. No further information was provided. On (b)(6) 2016 received allergy test discharge sheet and receipt, dated (b)(6) 2012: the consumer was seen as a new patient. Issues included: angioneurotic edema, urticaria idiopathic. Her next appointment was scheduled for (b)(6) 2012. The case outcome was unknown. No further information was provided. On (b)(6) 2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant), ch 50 (total), antinuclear antibody (ana), thyroid peroxidase ab, and thyroglobulin antibody testing and the diagnosis was angioedema. The case outcome was unknown. No further information was provided. On (b)(6) 2016 received allergy test note dated (b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant), ch 50 (total), antinuclear antibody (ana), thyroid peroxidase ab, and thyroglobulin antibody testing and the diagnosis was angioedema. The case outcome was unknown. No further information was provided. On (b)(6) 2016 received medication list, dated (b)(6) 2012: the consumer was directed to take omeprazole, 40mg check in the morning, 30-40 minutes before breakfast or after dinner; allegra 180mg check in the morning; zyrtec check at bedtime. She was also instructed to keep a food diary and to get blood done if she had any episodes of swelling within 4 hours. She was also told to implement a diet change that included avoiding spicy foods, caffeine, and soda. No further information was provided. On ( (b)(6) 2016 received allergy test note dated b)(6) 2012: the consumer underwent tryptase-serum, spep (serum protein electrophoresis), and upep (urine protein electrophoresis) testing on (b)(6) 2012 with a diagnosis of angioedema. She also underwent c-1 esterase inhibitor, serum, c-1 esterase inhibitor, functional, c-4, c1q (complement quant) testing and the diagnosis was anaphylaxis (unknown) and angioedema. The case outcome remained unknown. No further information was provided. On 27-apr-2016 received allergy test discharge sheet, dated (b)(6) 2012: the consumer was seen for an office visit routine on (b)(6) 2012 and had a percutaneous allergy test. Other issues included: rhinitis-chronic, angioneurotic edema, and gastroesophageal reflux disease/post nasal drip. Her next appointment was scheduled for (b)(6) 2012. The case outcome remained unknown. No further information was provided. On 10-jun-2016 product investigation results: the consumer returned one 90% empty tube of fixodent plus scope food seal 2 ounce with lot 30404 on 25-may-2016. Batch manufacturing check finds: no related complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 9 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. The product expired on 09-feb-2016, we do not test expired product; there is not an expiration date for this product in the united states, however in (b)(4) the expiration date is 3 years from the date the product is made. We don't intend for consumer to use product past the expiration date and cannot complete an investigation of expired product; this complaint will not be investigated any further. Based on the information given and the batch records, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 13-jun-2016 product investigation results: consumer returned one 90% empty tube of fixodent no zinc added neutral 2. 4 ounce with lot 41994 without the carton on 25-may-2016. Batch manufacturing check finds: no other complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 2 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign material. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. A sample from retain box # fp14-032 was sent for full finished product testing of representative retain sample. The results were passing for all tests performed. Based on the information given, the batch records and the retain sample testing, this complaint was investigated to the furthest extent possible and no manufacturing related quality issues found. No plant cause is identified for this complaint. Conclusion code: manufactured as intended based on investigation. The case outcome remained unknown. No further information was provided. On 16-jun-2016 received consumer follow-up: the consumer called on (b)(6) 2016 and stated that she was no longer using the fixodent and had not been to the doctor, either. She was not having any more symptoms since she stopped using the fixodent, and had not received any further treatment. The case outcome was recovered. No further information was provided. On 25-jul-2016 received consumer's medical bills: medical bill dated (b)(6) 2012: the consumer was admitted on (b)(6) 2012 and discharged on (b)(6) 2012. Patient type: inpatient. On (b)(6) 2012, she received pepcid, solu-medrol, klor-con 10, and (b)(4). On (b)(6) 2012, she received pepcid premixed, (b)(4), and ambien. She underwent a comprehensive metabolic panel, trypsin (serum), complete blood count with differential panel, urine culture, urinalysis screen, urine microscopic, pulse oximetry (multiple), and a 12 lead electrocardiogram on (b)(6) 2012. She underwent testing of her potassium level. Results were unknown. No further information was provided. On 23-aug-2016 received medical records: on (b)(6) 2012 emergency department chart: vital signs within normal limits except elevated systolic blood pressure at 147 mmhg and 144 mmhg, and depressed diastolic blood pressure at 58 mmhg. Allergies: iodine. Chief complaint: angioedema. Onset of symptoms was about 2 days ago. Patient tongue is swollen without airway occlusion at this time. Denies trouble breathing. No wheezing. No sensation of throat closing. No facial edema. No prior history of allergic reaction. Current medications: zoloft, levothyroxine, detrol la, pravastatin. Nursing assessment: within normal limits except for swollen tongue. Patient stated that the swelling to her tongue was starting to decrease. Clinician history of present illness: patient presents with tongue swelling and minimal lip swelling, with dizziness onset. Patient states she started 2 days ago on sunday with sudden tachycardia. Patient states she became very short of breath, along with feeling she may pass out. The episode lasted approximately 4 hours. Patient denies any chest pain with that. Experienced nausea along with dizziness. Patient states then this morning when she woke up she had edema underneath her tongue and had difficulty speaking. Did not use her epipen and came to the emergency room. Past medical and surgical history: hypothyroid, status post coronary stent, hypertension, history of tachycardia. Review of systems: negative. Physical exam: within normal limits. Drug orders: normal saline, pepcid intravenous 20 mg, solumedrol intravenous push 125 mg, (b)(4) injection 50 mg. Lab results within normal limits. Primary diagnosis: angioedema, near syncope, dizziness. Disposition: patient admitted to hospital. On (b)(6) 2012 hospital admission record: diagnosis/complaint: tachycardia, dizziness, swollen tongue, nausea. Date of admission: (b)(6) 2012. Date of discharge: (b)(6) 2012. Discharge diagnoses: angioedema, most likely reaction to her new denture paste. Palpitations, most likely anxiety related. Laboratory data within normal limits. Hospitalized because of angioedema, resolved with treatment. She has been having these reactions ever since she bought a new paste for her dentures although she stopped using it, but it is possible that some residue still left on the denture. Advised not to use it at all. The patient is also complaining of some dizziness, palpitations. Underwent cardiovascular evaluation, deemed to have normal coronaries and no cardiac issue. On (b)(6) 2012 hospital discharge record: chief complaint: swelling of the face, lips, episodes of palpitation with dizziness. The patient was hospitalized for further evaluation. The swelling of the tongue and face had completely resolved; she was alert, oriented, and back to her normal self. Past medical history: dyslipidemia, depression, and anxiety. Past surgical history: appendectomy, cholecystectomy, history of bowel resection, hysterectomy. History of coronary disease with myocardial infarction in 1990s. History of osteoarthritis, stress incontinence. Social history: she lives with her daughter. Review of systems: unremarkable. Physical examination: within normal limits. Vital signs normal except for depressed diastolic blood pressure at 46 mmhg. Assessment and plan: angioedema, most likely reaction to some chemicals in her paste since the patient is not on any ace inhibitors. Symptoms have resolved. Will continue treatment for the next 12 to 24 hours. Palpitations with presyncope. On (b)(6) 2012 consultation note: reason for consultation: evaluation of near-syncope, palpitation. History of present illness: in 2008, she was evaluated with at 2-d echocardiogram, a carotid ultrasound, an adenosine nuclear stress test, 24 hour holter monitoring. The patient presents to the emergency room for evaluation of angioedema. The patient had recently switched her denture paste and developed some angioedema, as well as swelling of her tongue. She presented to the emergency room for evaluation and also noted that she had been experiencing some dizziness and palpitations. Over the weekend she became extremely diaphoretic and slightly nauseated and her heart was racing. The patient's daughter states she gave her some antinausea medication and the patient calmed down. She states that she has frequent dizziness with position changes though and this has been longstanding and has not gotten worse in nature. She also states that she experienced some lightheadedness and shortness of breath and intermittent chest pain which she described as left-sided in nature, and a heavy pressure-type feeling, which comes and goes. It has no aggravating or relieving factors. The patient's daughter indicated that the patient has been experiencing some acid reflux, and they have attributed some chest discomfort to that, in the past. The patient states that she has occasionally used nitroglycerin for relief of the chest discomfort though, and states that the nitroglycerin has relieved the discomfort. Currently, she is comfortable without complaints. Past medical history: asthma, emphysema, hernia. Past surgical history: vein stripping with removal of muscle. Review of systems: negative. Physical examination: within normal limits, except depressed diastolic blood pressure at 56 mmhg. Laboratory values: within normal limits. Electrocardiogram reveals a slight wondering baseline and some mild nonspecific st-t wave changes. Impression: dizziness. Palpitations. Chest pressure. Angioedema, tongue swelling, resolving. Hypertension. Hyperlipidemia. Hypothyroidism. Emergency department chart dated (b)(6) 2012: arrival date: (b)(6) 2012. Chief complaint: allergic reaction, angioedema. Vital signs/data: within normal limits except elevated respirations at 24/min, blood pressure systolic elevated at 155 mmhg, and blood pressure diastolic decreased at 55 mmhg and 54 mmhg. Triage: no known provoking event, sensation of throat closing, has facial edema, non-pruritic rash, able to handle oral secretions. Prior allergic reaction to unknown. Nursing assessment: within normal limits. Clinician history of present illness: presenting problem started 1 hour ago. History and presentation is consistent with an acute allergic dermatitis. This is a recurring problem. Developed mild trouble breathing prior to arrival. Complains of local facial swelling. Describes sensation of throat closing up. Developed moderate angioedema. The patient states she woke approximately one hour ago noting that she had swelling of her lower lip and felt like her throat was closing. At this point in time these symptoms are moderately severe. No obvious historical cause for this dermatitis. Developed mild sense of swelling in the back of the throat and mouth. Patient has been able to talk normally and is swallowing without difficulty. Patient has had a recurrent history of similar symptoms since (b)(6) 2011. The patient had to be hospitalized previously for these similar symptoms. As of this time her family doctor has been unable to determine the cause of her angioedema symptoms. The patient as a history of hypertension, bladder incontinence, hypercalcemia. Review of systems: negative. Physical exam: within normal limits except for moderate swelling of lower lip. Progress notes: the lip swelling has gone down some although the patient still feels like her throat is slightly swollen. Drug orders: pepcid intravenous 20mg, solumedrol intravenous push 125mg, benadryl injection 50mg intravenous. Primary diagnosis: angioedema. Disposition: patient admitted to hospital, oxygen used during transport. Condition at discharge - improved. Hospitalization record dated (b)(6) 2012: the patient was admitted on (b)(6) 2012 with a diagnosis/complaint of angioedema, respiratory distress, possible allergic reaction. Date of discharge: (b)(6) 2012. Discharge diagnosis: angioedema, secondary to allergic reaction. Hospital course: hospitalized because of swelling of the left tongue and throat. Prior to arrival, daughter gave her epipen injection. Patient received intravenous steroids, (b)(4) and her symptoms completely resolved. The patient was observed overnight and remained asymptomatic. She is discharged with the following instructions: medrol dosepak to be started today until finished, prescription for epipen was given, (b)(4) 25mg by mouth daily, pepcid 20 mg by mouth twice a day in case patient has symptoms of swelling of the lips again, alpha 1 antitrypsin level was ordered and will be followed up as an outpatient, the patient is advised to follow up in the office in 1 week's time. Chief complaint: swelling of the lips, face, trouble breathing secondary to angioedema. History of present illness: the patient had yet another episode of her angioedema in which her lips, lower mouth, tongue, throat swell up. She was having trouble breathing. This happened spontaneously today (b)(6) 2012. The patient was given an epipen by her daughter and was brought to the emergency room. By the time she got to the emergency room, the swelling had improved significantly, but patient was still complaining of some irritation of the throat and she was hospitalized for further observation overnight. The patient has had multiple episodes of this since (b)(6) 2011. Initially, it was thought that she has used a new denture cream and was reacting to it. The patient removed that completely. Subsequently, the daughter thought she may be allergic to vitamin d. She eliminated that and yet she had another episode today. Review of systems: negative. Home medications include prednisone, prevacid, ecotrin. Physical examination: within normal limits. Assessment and plan: allergic reaction versus recurrent angioedema of unclear etiology. We will check the alpha 1-antitrypsin level to rule out its deficiency as the cause of recurrent angioedema. The patient will be given benadryl, steroids, and h2 blocker. Her home medications will be continued. On (b)(6) 2012 discharge cumulative trend report: all labs within normal limits except for elevated glucose at 144 mg/dl. The case outcome was improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2016-00004 |
| MDR Report Key | 5685271 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-03-10 |
| Date Mfgr Received | 2016-08-23 |
| Date Added to Maude | 2016-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENTDENTURECAREDENTUREADHESIVEFOODSEALCRMFRESH |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2016-05-27 |
| Returned To Mfg | 2016-05-25 |
| Lot Number | 30404 |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTOR & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-05-27 |