MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-11-23 for FIXODENTDENTURECAREDENTUREADHESIVECNTRLCRMNOFLAVORSCENT2.0OZ manufactured by Proctor & Gamble Manufacturing Co..
[31932247]
Product and lot number not provided by reporter therefore unable to proceed with product investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
[31932248]
Kidney failure [renal failure]. Neuropathy [neuropathy peripheral]. Insomnia [insomnia]. Diarrhea [diarrhoea]. Nausea [nausea]. Fell (and hit head) [fall]. (fell) and hit head [head injury]. Burning sensation gums [oral discomfort]. Foaming at mouth [foaming at mouth]. Dry mouth [dry mouth]. Losing balance [balance disorder]. Periods of confusion [confusional state]. Soreness gums [gingival pain]. Muscle weakness; dropping items - muscular [muscular weakness]. Periods of forgetfulness [memory impairment]. Swelling of the feet [peripheral swelling]. Muscles aching [myalgia]. Abdominal pain [abdominal pain]. Blood pressure was high [hypertension]. Dizziness [dizziness]. Lips were white from the foam [lip discolouration]. Burning sensation in hands and feet [burning sensation]. Pain in hands and feet [pain in extremity]. Tingling in hands and feet [paraesthesia]. Numbness in hands and feet [hypoaesthesia]. Difficulty walking [gait disturbance]. Burning sensation in stomach [dyspepsia]. Vomiting [vomiting]. Anemic [anaemia]. Immune system was low [immune system disorder]. Pain in stomach [abdominal pain upper]. Shortness of breath [dyspnoea]. Low/reduced red blood cell count [red blood cell count decreased]. Nerve damage [nerve injury]. (b)(6) which is 900 reduced to 800 and she had never been below 900 viral load until now [blood (b)(6) rna decreased]. Aches [pain]. Weakness [asthenia]. Sore mouth [oral pain]. Stomach problems [gastric disorder]. Intestinal bacterial infection [enteritis infectious]. Case description: a (b)(6) female consumer with (b)(6) well controlled and receiving treatment since 1998 used fixodent denture adhesive, version unknown cream 1 application, once a day as directed beginning in (b)(6) 2015, through (b)(6) 2015 and reported developing kidney failure, neuropathy, insomnia and nerve damage. She had gotten new dentures in (b)(6) 2015 and continued to use fixodent until her dentist advised her to stop when her dentures were adjusted in (b)(6). The consumer explained that her initial symptoms included burning gums, foaming of the mouth, and her lips were white from the foam. She experienced a burning sensation, pain, tingling, and numbness in her hands and feet. She began dropping things; she had muscle weakness and muscle aches all over her body. She described having difficulty walking, dizziness, problems with her balance, burning sensation in stomach, diarrhea, nausea, vomiting, dry mouth, sore gums and mouth, and swollen feet. She had episodes of confusion and forgetfulness, hypertension, shortness of breath, and she was unable to do any work around her house due to her symptoms that had progressively worsened leading to a fall where she hit her head on her dresser, rescue was called, and she was taken to the hospital and hospitalized for five days. While in the hospital, a stool sample revealed she had an intestinal bacterial infection. The consumer's red blood cell count was low; she was anemic. Her immune system was low. Her (b)(6) viral load which is 900 reduced to 800 and she clarified she had never been below 900 viral load until this experience. She saw her primary physician and the doctors were concerned about her immune system being low and all her health issues including a diagnosis of kidney failure. Treatment included high doses of medication for the neuropathy, unspecified medication for nausea and vomiting, antibiotics to treat the bacterial infection in the intestines, antihypertensives to treat hypertension, and b12 injections for anemia. Also, she was using a walker now to help with the weakness and balance problems. While she was still short of breath, her blood pressure and swelling in her feet had improved. The overall case outcome was improved. Relevant history: drug allergies to ibuprofen, meloxicam, and tolmetin sodium. Medical history: denture wearer (dentures) and (b)(6) (being treated for (b)(6) since 1998). Concomitant product(s): none reported. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
[54332387]
Return of product was requested. Reporter returned product sample on 23-feb-2016. Product investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
[54332388]
Arthralgia; positive for arthralgias; joint pain [arthralgia]. Hematuria [haematuria]. Bilirubin total decreased [blood bilirubin decreased]. Angular cheilitis [angular cheilitis]. Red blood cell count decreased [red blood cell count decreased]. Hemoglobin decreased [haemoglobin decreased]. Mean cell volume increased [mean cell volume increased]. Mean cell hemoglobin increased [mean cell haemoglobin increased]. Lymphocyte percentage increased [lymphocyte percentage increased]. Granulocyte percentage decreased [granulocytes abnormal]. Fatigue [fatigue]. Night sweats intermittently [night sweats]. Doesn't have much appetite [decreased appetite]. Bloated stomach, worse after a meal; mild distended [abdominal distension]. Oral thrush [oral candidiasis]. Mild tender to palpitation over epigastrium and right upper quadrant [abdominal tenderness]. Malaise [malaise]. Slight yellowish discoloration of hard palate (and lateral tongue) [oral mucosal discolouration]. Yellowish discoloration of lateral tongue [tongue discolouration]. Back pain [back pain]. Sensory change, light touch sensation decreased to level of mid shin on left and ankle on right [sensory loss]. Vibration diminished (but present at left foot and normal on right) [vibration test abnormal]. Unable to elicit patellar reflexes [areflexia]. Unable to elicit achilles reflexes [hyporeflexia]. Oral plaques [oropharyngeal plaque]. Decreased temperature on left foot [temperature difference of extremities]. Mouth sores [stomatitis]. Ulcerations on soft palate [mouth ulceration]. Diaphoresis [hyperhidrosis]. Chest pain [chest pain]. Systolic murmur [cardiac murmur]. Acute kidney injury [acute kidney injury]. Dehydration [dehydration]. Low lung volumes (with borderline cardiomegaly) [pulmonary function test decreased]. (low lung volumes with) borderline cardiomegaly [cardiomegaly]. Zinc poisoning/toxicity [metal poisoning]. Blood albumin decreased [blood albumin decreased]. Hematocrit decreased [haematocrit decreased]. Headaches [headache]. Depression [depression]. Dysuria [dysuria]. Urinary frequency [pollakiuria]. Decreased concentration [disturbance in attention]. Agitation [agitation]. Cough [cough]. Sore throat [oropharyngeal pain]. Trouble swallowing [dysphagia]. Blood creatinine increased (patient in er found to have increased creatinine to 1. 52, lab result not provided) [blood creatinine increased]. Case description: on 04-feb-2016 received medical records beginning (b)(6) 2015 containing patient preoperative risk assessment for surgery (turp-transurethral resection ablation of prostate), surgery turp progress notes, transurethral resection prostate procedure follow-up notes, infectious diseases (b)(6) follow-up physician's note dated (b)(6) 2015, post urology surgery physician's note dated (b)(6) 2015, internal medicine physician's progress note dated (b)(6) 2015, internal medicine physician's progress note dated (b)(6) 2015, internal medicine physician's follow-up progress notes (b)(6) 2015, emergency medicine physicians' notes dated (b)(6) 2015; hospital admission (b)(6) 2015, discharged (b)(6) 2015, hospitalist progress notes, laboratory findings, hospital follow-up physician's visit on (b)(6) 2015, infectious disease follow-up physician visit on (b)(6) 2015, er visit and physician progress notes on (b)(6) 2015, internal medicine physician's progress note dated (b)(6) 2015, laboratory values (b)(6) 2015 provided, and infectious disease follow-up physician visit dated (b)(6) 2015 containing exact same documentation as (b)(6) 2015 visit with medication change noted (gabapentin discontinued from concomitant list and lyrica added): on (b)(6) 2015 the presently (b)(6), presented to the clinic for preoperative risk assessment prior to turp (transurethral resection ablation of prostate using the thunder beat button). Past medical history learned as follows: allergy: seasonal allergies, drug allergies: ibuprofen, meloxicam, methocarbamol, sulfa (sulfonamide antibiotics, and tolmetin sodium. Medical histories: reactive airway disease on albuterol, hypertension taking norvasc, (b)(6) infection and taking combivir and kaletra, mental health problems, bipolar disorder, schizophrenia on seroquel, eczema, chronic back pain, hyperlipidemia, peripheral neuropathy and taking gabapentin, hypothyroidism and on levothyroxine, anemia, benign prostatic hyperplasia on flomax and current indication for his surgery; gerd and taking prilosec (omeprazole), wears glasses, full upper, partials on bottom; current smoker, previous history of drug abuse (powder cocaine); none since (b)(6) 2014; denied intravenous drug use, previous surgery included right shoulder surgery and wisdom teeth extraction. Concomitant product(s): flomax 1 capsule, 0. 4mg by mouth daily, ultram 50 mg tablet, 1-2 tablets by mouth every 6 hours as needed for pain, kenalog 0. 1% cream applied topically two times daily, albuterol (proventiinentolin) inhaler 2 puffs every 4-6 hours as needed, acetaminophen 500 mg tablet, take 2 tablets every six hours for pain, combivir 150-300mg per tablet, take 1 tablet twice a day, levothyroxine 50 mcg, take 1 tablet daily, wellbutrin sr 150mg 12 hour tablet daily, peridex 0. 12% solution, with 15 ml in the mouth or throat twice daily, gabapentin take two 300 mg tablets by mouth three times daily, norvasc 10 mg tablet 1 tablet daily, kaletra (lopinavir-ritonavir) 200-50 mg per tablet take 2 tablets by mouth two times a day, multivitamin, omeprazole (prilosec 40 mg capsule) take 1 capsule daily, pravachol take 1 20mg tablet daily, seroquel400 mg tablet, take 2 tablets by mouth daily, and mycostatin (nystatin) 100,000 unit/ml suspension, 5 ml by mouth three times daily. Patient here for benign prostatic hypertrophy with outflow obstruction/lower urinary tract symptoms. Patient had continued problems voiding with an enlarged prostate. Vss: t-97. 9 f, p-80, b/p: 124/64. Review of systems all negative with exception of positive hematuria; denies gross blood in urine; denies kidney stones. No contraindications for surgery. On (b)(6) 2015, the surgical procedure transurethral resection prostate was completed. On (b)(6) 2015 infectious diseases hiv follow-up physician's note: the currently (b)(6) patient with a history of (b)(6) presented for follow-up on (b)(6) 2015. Since the last visit the patient had been taking his anti-retrovirals as directed without any missed doses. He had been feeling well. Vss: t-97. 8 f, p-71, b/p: 134/68. He underwent a turp and recovering well. He stopped his flomax. The patient denied fevers, chills or night sweats. No shortness of breath, cough, or chest pain. The patient had no bowel or bladder discomfort. No neurological deficits were being endorsed. Patient's weight had increased by 14 lbs since (b)(6) 2013; he had lost 10 lbs since (b)(6) 2014; overall weight has been stable. Review of systems were as follows: constitutional: negative for anorexia, chills, fatigue, fevers, night sweats and weight loss; eyes: negative for visual disturbance, head, ears, eyes, neck, throat (heent): negative for nasal congestion and sore throat; lips normal without lesions and buccal mucosa normal; abnormal findings: dentition: upper dentures, angular cheilitis. Respiratory: negative for cough, dyspnea on exertion and hemoptysis; cardiovascular: negative for chest pressure/discomfort and irregular heartbeat. Gastrointestinal was negative for change to bowel habits, constipation, diarrhea, jaundice and melena, nausea and vomiting are better; genitourinary: negative for dysuria & nocturia; integument/breast: negative for rash; hematologic/lymphatic: negative for bruising and lymphadenopathy; musculoskeletal positive for arthralgias; neurological: negative for dizziness, gait problems, and headaches. Behavioral/psychiatric: negative for behavior problems; endocrine: negative for temperature intolerance; allergic/immunologic: negative for urticaria. Physician's assessment provided as follows: the patient's (b)(6) was diagnosed in 1998 and he has been virally suppressed since 2009. Patient has been on kaletra and combivir and medication compliant. Past anti-retroviral therapy consisted of combivir plus abacavir plus nevirapine. These medications were stopped in approximately 2003, and he was off therapy until (b)(6) 2009 when he was started on current medicines. They were reinitiated due to decreasing cd4 count and increasing viral load. Patient is tolerating the kaletra and combivir well except for anemia noted since 2009. Anemia potentially associated with combivir. While anti-retrovirals were continued, physician will consider replacing kaletra/combivir with other agent that is not going to cause anemia. Tobacco abuse ongoing. On (b)(6) 2015 urology postoperative turp physician's follow-up note: the male patient presents for evaluation of luts (lower urinary tract symptoms) and testicular pain described as dull ache that started few days following the turp surgery performed (b)(6) 2015. T-98. 4f, b/p: 146/82, p-82, r-20. Urine dipstick contained +1 leukocytes, +2 protein; microscopic urine analysis: plenty of wbcs, no rods can be seen, and scant rbcs. Physician's plan to send urine for culture. Patient given 7 days of nitrofurantoin. On (b)(6) 2015 internal medicine physician's progress note: patient presented to clinic with 4 day history of chest congestion with productive cough of thick green sputum. He had a chest x-ray done in the emergency department two days ago that showed no acute processes and he left before being seen by the doctor. He denied shortness of breath, fever, chills, nausea, vomiting or any additional symptoms. Concomitant medications were same medicines except gabapentin increased to 300mg capsule, take 3 capsules, 900mg, three times daily. Assessment/plan: viral upper respiratory infection and patient to continue supportive care with albuterol as needed; zyrtec 10 mg tablet, 1 tablet by mouth daily to treat his seasonal allergies. On (b)(6) 2015, internal medicine physician's progress note: patient presented with illness, fatigue, indigestion for which he had been taking pepto-bismol. The patient had experienced night sweats intermittently. He did not have much appetite and had a bloated stomach that was worse after a meal. He complained of nausea but no vomiting. He had not taken his medications today due to nausea. He had a dentist appointment yesterday, he had oral thrush, and he was given nystatin. Vss: t-97. 6f, p-66, b/p: 136/80; review of systems: normal with exception of positive for nausea, mild tender to palpitation over epigastrium and right upper quadrant, and mildly distended. Additionally, patient had a white ring around his mouth that he said was polident. Assessment/plan: epigastric pain, indigestion, nausea treated with zofran 4 mg, take 1-2 tablets by mouth every 8 hours as needed. On (b)(6) 2015 internal medicine physician's follow-up progress note: the patient presents for follow-up for abdominal pain which is resolved. An abdominal ultrasound was completed and unremarkable on (b)(6) 2015. Patient continued to have nausea and felt weak all over; worse in morning and improves through day. Patient's b12 in (b)(6) 2014 was normal. Patient's mouth foaming with denture cream when dentures are in mouth. Patient will follow-up with dentist soon. Review of systems all normal except positive for malaise/fatigue. Physician noted the patient edentulous on top; slight yellowish discoloration on hard palate and lateral tongue. Assessment/plan: oral thrush, refilled nystatin as patient does not tolerate peridex due to burning in mouth. Patient's fatigue likely medication effect, more of a sleep inertia as it improves during the day. Concomitant medications of seroquel, triamcinolone (kenalog), acetaminophen, amlodipine, levothyroxine, pravastatin, lopinavir-ritonavir (kaletra), lamivudine-zidovudine (combivir), bupropion (wellbutrin), chlorhexidine, omeprazole, acetaminophen-codeine as needed, gabapentin (900 mg, 3 times a day), albuterol, cetirizine, multivitamin, tramadol, and ondansetron (zofran) maintained at present doses. On (b)(6) 2015 internal medicine physician's follow-up progress note: the currently (b)(6) male patient presented with burning in both feet that began a few days ago in (b)(6) 2015. The patient had experienced tingling or a numbness for a longer time, but he had recently started having burning on left foot. The patient was already on gabapentin which was started for sciatica. The patient described the sensation as like walking barefoot on rocks. Vss: t-98. 1f, p-80, b/p-123/68. Review of systems revealed back pain, tingling and sensory changes. Also, noted nystatin had helped with the patient's foaming and soreness of his gums. Physical examination: oropharynx was clear and moist: plaques seen previously had resolved. Neurological findings were documented as follows: unable to elicit patellar or achilles reflexes even with recruitment, light touch sensation (gauze) decreased to level of shin on left and ankle on right, monofilament decreased in same distribution as gauze, vibration diminished but present on left foot and normal on right, decreased temperature on left foot, normal on right, and pinprick present and symmetric. Diagnosis/plan: mononeuropathy due to underlying disease and right lumbar radiculopathy unchanged. The physician increased the patient's gabapentin to 1200mg in the morning and evening and 900mg at noon. On (b)(6) 2015 emergency medicine (er) physician's note: patient visited emergency room with chief complaint of foot pain, feeling new onset weakness, dizziness, loss of balance in the last two weeks, falling today around noon and hitting his head on dresser. He described feeling confused, forgetting to pay for items, and forgetting doctors' appointments which were unusual for him. He reported nausea and vomiting for one week including several times today unrelieved by zofran, and he complained of unrelieved neuropathy. Also, patient feels abdomen distended. He had difficulty walking for the last two weeks. He takes gabapentin 1200mg in the morning and evening, and 900mg at noon. He received dentures in june using fixodent initially for his gums. Later on he experienced foaming in the mouth, gum pain, and ulcerations. Patient's chart review indicated patient was prescribed nystatin mouth wash for oral candidiasis. According to the patient, the dentist fixed his dentures so that he doesn't require fixodent: the dentist also printed out information for the patient regarding zinc toxicity. Physical exam: vss: t-98. 3f, p-62, r-16, b/p: 122/77 review of systems: patient complained of diaphoresis and fatigue: heent: positive for mouth sores, ulcerations on soft palate: respiratory: positive shortness of breath, effort normal, breath sounds normal, no respiratory distress, no wheezes or rales. Cardiovascular: chest pain present: systolic murmur heard: normal rate and regular rhythm, no gallop, or friction rub; gastrointestinal: positive nausea, vomiting, diarrhea: abdomen soft, bowel sounds normal: exhibits distension, diffuse abdominal tenderness with positive fluid wave: no rebound or guarding. Genitourinary: negative for discharge, penile swelling, genital sores & penile pain. Musculoskeletal: back pain present: normal range of motion: no edema. Skin: negative rash: warm & dry; not diaphoretic. The patient was admitted to the hospital for observation due to dehydration and acute kidney injury that appeared to be contributing to patient's presentation. Patient given morphine and 1 liter of intravenous fluids. Final diagnoses: acute kidney injury, abdominal pain, nausea, & vomiting, neuropathy. Abnormal laboratory results were decreased hemoglobin 11. 5 g/dl, decreased hematocrit 33. 3%, and albumin decreased 3. 9 g/l. On (b)(6) 2015 physician's (hospitalist) discharge summary- hospital course: the male patient with history of (b)(6), hypertension, schizophrenia with paranoia, peripheral neuropathy and multiple other problems was admitted through the er with complaints of dizziness, abdominal pain, nausea, vomiting, and peripheral neuropathy since using fixodent for his dentures. Patient showed concerns of possible zinc toxicity. Zinc level pending at time of discharge. Patient was found to have increase creatinine to 1. 52 from a baseline of 1. 06 - 1. 2 a month ago. He was also noted to have some mild anemia. Ekg shows normal sinus rhythm of 66 with non-specific t wave changes and no significant change from previous ekgs. Head ct was unremarkable dated (b)(6) 2015. Also on (b)(6) 2015, a chest x-ray with comparison to (b)(6) 2015 chest x-ray showed low lung volumes with borderline mild cardiomegaly. Treatment included 1 l bolus of sodium chloride (nacl) intravenous (iv) fluids, iv morphine, and iv zofran. Patient was admitted under observation and given iv fluids with improvement of acute kidney injury (aki) and his symptoms resolved. Physical and occupational therapy followed patient during stay in hospital and front wheel walker was provided at time of discharge. Patient to continue home medications for other chronic conditions which remain stable. The patient's condition at discharge was much improved & stable. On (b)(6) 2015 hospital follow-up physician's visit: the patient presents for follow-up to hospital visit where he was in for observation for nausea and vomiting. Patient's stool pathology report returned after hospital discharge positive for salmonella. His nausea, vomiting, diarrhea continues and he feels run down. The patient had not noticed any blood in his stool. The patient continued to express concern about zinc toxicity from his denture cream as a cause of his neuropathy. His zinc level obtained in the hospital was within normal range. Review of systems: constitutional: positive malaise/fatigue, gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, dysuria and frequency: neurological: positive tingling, weakness, headaches. Psychiatric: positive depression. Vs: t-98. 3, p-81, b/p: 149/67 physician exam: well-nourished, no distress, normal cardiac rate, regular rhythm, normal heart sounds and intact distal pulses: no murmur heard: breath sounds normal, no respiratory distress, no wheezes: abdomen soft, no distension: mild epigastric tenderness: no edema. Assessment/plan: (b)(6) follow-up scheduled; macrocytic anemia, dysuria to repeat urinalysis: salmonella gastroenteritis-given amoxicillin: nausea possibly related to a persistent gastroenteritis due to positive salmonella, continue zofran: idiopathic progressive neuropathy, etiology not clearly defined with possibility of (b)(6) medication induced and potentially low b12 as causes for neuropathy; repeating b12 level today. On (b)(6) 2015 infectious disease physician's follow-up progress notes: the patient presented to the clinic over 20 minutes late and arrived in a wheelchair. The patient reported recent hospital admission for confusion, dizziness, balance problems, nausea, vomiting abdominal pain, peripheral neuropathy that he apparently developed after using fixodent. He stopped using fixodent and got admitted for further evaluation. On admission there his vital signs were stable, however, it was noted that he had a creatinine of 1. 5. He was given iv fluids in addition to zofran and morphine. He was placed on observation and improved. No major changes to his medications were noted. Patient was seen in the internal medicine clinic on (b)(6) 2015 and noted that his stool was positive for salmonella. There is no overt diarrhea. He was placed on amoxicillin 500mg three times daily for 7 days. Patient concerned about zinc toxicity associated with the denture cream and concerned about further workup. Patient was seen in the infectious disease clinic in (b)(6) 2015 at which time he was stable. He underwent turp procedure for urinary symptoms, placed on ciprofloxacin, and at last clinic visit doing fairly well. Current review of symptoms: positive for dizziness, confusion, headache, peripheral neuropathy of both legs but able to be delayed with a walker, nausea, vomiting, abdominal discomfort, and mild dysuria. He denies overt chills or fevers. Vss: t-98. 4, p-75, b/p: 125/68; physical exam: all systems were normal; patient extremities normal with no edema: patient had normal strength in lower extremities. He was able to stand and ambulate with a walker to a wheelchair. Neurologic: grossly normal. 2009. His (b)(6) is under control for the most part. He has a viral load of 28 copies. Cd4 counts are well in the 800- 1000 range. The recent symptoms potentially could be from combivir. He had an (b)(6) genotype done on (b)(6) 2007 which revealed k103n and mutation but otherwise unremarkable. Plan: continue current anti-retrovirals for now. (b)(6) 2015 emergency medicine physician progress note: patient presented to er with chief complaints of leg swelling and pain. Patient had swelling in lower left extremity overnight and today, elevated it with resolution of swelling and now with continued leg pain. (patient had photo of leg swelling on cell phone, but physical examination benign, bilateral lower extremities symmetric without edema. ) patient blames multiple symptoms including decreased concentration, agitation, sore throat, trouble swallowing and cough on zinc poisoning from denture cream he used two months ago and has since discontinued. Patient refused tylenol for lower extremity pain, refused to wait long enough for ultrasound, and wanted to go home to take his home medications of tramadol and tylenol #3. Patient left er without treatment. He was ambulatory at time of discharge from the emergency room. On (b)(6) 2015 internal medicine physician's progress note: patient presented with complaint of uncontrolled bowels. Also, he presented with left hip pain. He had attempted to help a woman down from a ledge and she fell on him, he landed on his left hip which had been hurting since the incident about two weeks ago. When physician asked directly about his uncontrolled bowels, he stated his bowels were not a problem. The patient clarified that he continued to feel run down and in need of an "upper. " he continued to assert concerns regarding zinc toxicity due to denture cream. He asserted his neuropathy and kidney disease were diagnosed at the same time. His chart was reviewed and first mention of neuropathy was (b)(6) 2014 and first mention of kidney disease was early 2013. Review of systems: constitutional: positive for malaise/fatigue; negative for fever or chills; heent: negative for congestion; respiratory: positive for shortness of breath; negative for cough; gastrointestinal: negative for abdominal pain, diarrhea, constipation; negative for dysuria and frequency; musculoskeletal: positive for back pain and joint pain; skin: negative for rash; neurological: positive for sensory change and weakness; negative for headaches. Psychiatric: negative for depression. Physical exam: t-98. 4, p-86, bip: 128172; patient appears well nourished; no distress; cardiovascular: normal rate, rhythm, normal heart sounds; intact distal pulses; no gallop, no friction rub; no murmur heard. Pulmonary: no respiratory distress; no wheezes; no rales; abdominal: soft, bowel sounds normal; no distension, no mass; no tenderness; musculoskeletal: positive for tenderness along left posterior iliac crest without deformity; no edema; skin: warm, not diaphoretic; no erythema. Assessment/plan: peripheral polyneuropathy; fatigue may be medication related given high dose of gabapentin; plan to switch from gabapentin to lyrica to see if less sedating; emg planned for future. Pregabalin (lyrica) 50 mg capsule 1 capsule three times daily; hip strain, left, initial encounter: flexeril 10 mg tablet, 1 tablet two times daily as needed for muscle spasms. All other medicines maintained. On (b)(6) 2015 pertinent laboratory results provided dated (b)(6) 2015 were as follows: red blood cell count: 3. 40 decreasing (normal range 4. 30- 5. 60); hemoglobin 12. 1 gldl decreased (normal range 13. 2 -16. 2); hematocrit 35. 2% decreased (normal range 38. 8- 46. 4) mean corpuscular volume (mcv) 1 03. 5ft. Elevated (normal range 79- 93. 3); mean corpuscular hemoglobin 35. 6 (normal range 26. 7- 31. 9); granulocytes percentage: 45% decreased, normal range 45. 5 -79. 7); lymphocytes percentage: 44% normal range (20- 50); blood creatinine 1. 04 normal; alkaline phosphatase 88 normal; albumin 4. 0 normal; (b)(6) quantitative value was 26; cd4ab value was 814 and cd4tcell 36. On (b)(6) 2015 infectious disease (b)(6) follow-up physician's note: the physician's note was an identical narrative as previous physician's follow-up visit dated (b)(6) 2015 as the patient appeared to have missed his recent appointment. Current outpatient prescriptions were acetaminophen-codeine (tylenol #3) take 1-2 tablets every six hours; albuterol inhaler 1-2 puffs inhaled every 4-6 hours as needed; norvasc 10 mg tablet, take 1 tablet daily; wellbutrin sr 150mg 12 hr tablet; zyrtec 10 mg tablet, take 1 tablet as needed daily; peridex use as directed with 15 ml in the mouth/throat twice daily; flexeril 10 mg take 1 tablet two times daily as needed; kaletra 200-50mg tablet, take 2 tablets twice daily; combivir 150-300mg per tablet, take 1 tablet twice daily; levothyroxine 50 mg take 1 tablet daily; multivitamin take 1 tablet daily; omeprazole (prilosec) 40 mg, take 1 capsule daily; zofran 4 mg, take 1-2 tablets every 8 hours as needed for nausea; pravastatin 20 mg tablet, take 1 tablet by mouth daily (patient taking differently: taking 40 mg daily); pregabalin (lyrica) 50 mg capsule, take 1 capsule three times daily; seroquel 400 mg, take 2 tablets daily; ultram (tramadol) 50 mg tablet take 1-2 tablets every 6 hours as needed for pain.
Patient Sequence No: 1, Text Type: D, B5
[55352189]
Return of product was requested. Reporter returned product sample on (b)(6) 2016. The consumer returned one empty tube of fixodent denture care denture adhesive control cream 2. 0oz. The product was returned to the manufacturing plant for evaluation. The consumer's returned product was produced (b)(6) 2004. The records for this product have since been archived. The tube started production in (b)(6) 2004 for global code allocation system (gcas) code (b)(4). The investigation concluded that based on the evidence and provided sample, the tube gcas was ran in digital specs tube that shown an obsolete date of the tube was (b)(6) 2008. While there is not an expiration date for this product in the united states, the product investigation conclusion code was expired product. Pma/510(k) #k 945200 continued in additional info section. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55352190]
Kidney failure [renal failure] neuropathy [neuropathy peripheral] insomnia [insomnia] diarrhea; uncontrolled bowels [diarrhoea] nausea [nausea] fell (and hit head) [fall] (fell) and hit head [head injury] burning sensation gums [oral discomfort] foaming at mouth [foaming at mouth] dry mouth [dry mouth] losing balance [balance disorder] periods of confusion [confusional state] soreness gums [gingival pain] muscle weakness; dropping items - muscular [muscular weakness] periods of forgetfulness [memory impairment] continued in additional info section...
Patient Sequence No: 1, Text Type: D, B5
[64144378]
Return of product was requested. Reporter returned product sample on 23-feb-2016. The consumer returned one empty tube of fixodent denture care denture adhesive control cream 2. 0 oz. The product was returned to the manufacturing plant for evaluation. The consumer's returned product was produced 21-dec-2004. The records for this product have since been archived. The tube started production in april 2004 for global code allocation system (gcas) (b)(4). The investigation concluded that based on the evidence and provided sample, the tube gcas was ran in digital specs tube that shown an obsolete date of the tube was 23-sep-2008. While there is not an expiration date for this product in the united states, the product investigation conclusion code was expired product.
Patient Sequence No: 1, Text Type: N, H10
[64144379]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2015-00012 |
| MDR Report Key | 5243269 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-11-23 |
| Date of Report | 2015-10-28 |
| Date Mfgr Received | 2016-12-20 |
| Date Added to Maude | 2015-11-23 |
| 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 | FIXODENTDENTURECAREDENTUREADHESIVECNTRLCRMNOFLAVORSCENT2.0OZ |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2015-11-23 |
| Returned To Mfg | 2016-02-23 |
| Lot Number | 4357GT1 |
| 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 | 2015-11-23 |