MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2016-09-29 for ALWAYSPADSULTRAULTRABASEVERWINGREGNORNONDO manufactured by Procter & Gamble Gmbh & Co. Manufacturing Ohe.
[55926779]
Return of product has been requested. Lot number provided by reporter and investigation is in progress. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[55926780]
Respiratory symptoms [respiratory disorder]. Chemical poisoning reaction - from the always ultra scented sanitary napkins. Cortisone shot central nervous system symptoms [nervous system disorder]. Extreme skin symptoms [skin disorder]. Rash all over the body [rash generalised]. Headache. Can no longer fall asleep well/sleeping difficulties/cannot sleep [insomnia]. Itching [pruritus]. Chemical exposure - from the always ultra scented sanitary napkins [medical device site reaction]. Case description: a husband reported on 30-aug-2016 via phone that his wife used always ultra pad beginning on an unknown date and she had a chemical poisoning reaction that included a rash all over her body and required that she be taken into the hospital. He described how they could not figure out what caused her symptoms at first, but then realized it started the same time as her menstrual period, on (b)(6) 2016. He stated that the reaction was so severe that his wife needed cortisone shots right away and that she then developed cortisone shot central nervous system symptoms, including a headache and difficulty sleeping, which have stayed. He reported that she is no longer in the hospital, that the rash lasted 3 days, but the central nervous system symptoms have not resolved and she can no longer fall asleep well. He stated that he was concerned that she was subjected to chemicals and that her symptoms have remained. He reported that she was treated with a cortisone shot and pills at the hospital and was given antihistamine tablets to take home. He described that she has drunk a lot of water and rested, but his concern is that the central nervous system symptoms are so new, and he is especially puzzled by how these sleep symptoms can stay. Product use was discontinued after the incident. The case outcome was improved. No further information was provided. On 30-aug-2016 consumer follow-up: the husband reported that his wife had to be taken to the emergency room on (b)(6) 2016 because of extreme skin symptoms, itching and respiratory symptoms. He stated that they spent four hours at the emergency room clinic and that a cortisone shot was given at the emergency room as well as a cortisone and antihistamine cure as treatment. He reported that the skin symptoms continued for six days, and as a result of the poisoning there were central nervous system symptoms and sleeping difficulties, and he questioned how these will be treated. He stated that her skin symptoms were even more severe before the first aid. The case outcome remained improved. No further information was provided. On 09-sep-2016 consumer follow-up: the husband reported that regarding his wife's situation they have been in contact with the healthcare center about melatonin and they told her to try it and that it is a very typical symptom when you ingest those kinds of chemicals - that you have trouble sleeping and you miss the deep sleeping phase. He stated that melatonin helps when you take two half milligram tablets. He reported that he has no doubt about what might have caused this. The case outcome remained improved. No further information was provided. On 09-sep-2016 consumer follow-up: the husband reported that they went to first aid and his wife called the healthcare center contact person and told her of the case and received the instructions for melatonin. He stated that now they haven't gone anywhere, as it futile when you know what the chemical is and it serves no purpose to visit the healthcare center doctor. He described that what can be found online is something called chemical exposure and it's what has become active for her and they are hoping to make it go away somehow. He reported that they will try to have a look there again next week and then will have to see a specialized doctor. He stated that to date, they have only gone to the first aid healthcare center and that his wife is taking melatonin every night, a half hour before going to sleep. The case outcome remained improved. No further information was provided. On 29-sep-2016 batch manufacturing records check completed: conclusion code: manufactured as intended based on investigation. Summary: the production lot code and product description was accurate and legitimate at the time of the intake call. Sap production planning and confirmation records confirmed that line 19 produced brand code (b)(4) (alw ult rw 24x14sp prosp2 nord b3 nononm) with the process order (b)(4) on julian date (6045) february 15th 2016 at 02:44am. Quality reports passed quality assurance criteria to release and ship brand code (b)(4) to confirm that the product was manufactured as intended. The site quality alert system was searched for the production code identified and selected time frame before and after the production date and there were no quality events on that line. The line was running without any stops around the complaint time. Production records were reviewed and indicated the subject product was manufactured as intended without sent, and no deviations were observed. The quality check for scent free product after the change from scented product was passed to confirm that we produced as intended and on the same time to confirm that the onm pump is not in operation for a non scent product. The consumer stating that the accident coming from our scented product. The submitted production code from the complaint was product without any scent on the pad. An allergic reaction from scent on the product can be ruled out.
Patient Sequence No: 1, Text Type: D, B5
[58168197]
An accurate and legitimate lot number was provided by the reporter. Review of production records and quality reports concluded that the product was manufactured as intended based on investigation. The reporter indicated return of the product, but manufacturing plant has not received product. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[58168198]
Respiratory symptoms [respiratory disorder]. Chemical poisoning reaction - from the always ultra scented sanitary napkins [chemical poisoning]. Cortisone shot central nervous system symptoms [nervous system disorder] extreme skin symptoms [skin disorder]. Rash all over the body [rash generalised]. Headache [headache]. Sleeping difficulties/cannot sleep [insomnia]. Itching [pruritus]. Chemical exposure - from the always ultra scented sanitary napkins [medical device site reaction]. Can no longer fall asleep well/falling asleep takes longer [initial insomnia] deep sleep stage is still missing [irregular sleep phase]. Case description: a husband reported on (b)(6) 2016 via phone that his wife used always ultra pad beginning on an unknown date and she had a chemical poisoning reaction that included a rash all over her body and required that she be taken into the hospital. He described how they could not figure out what caused her symptoms at first, but then realized it started the same time as her menstrual period, on (b)(6) 2016. He stated that the reaction was so severe that his wife needed cortisone shots right away and that she then developed cortisone shot central nervous system symptoms, including a headache and difficulty sleeping, which have stayed. He reported that she is no longer in the hospital, that the rash lasted 3 days, but the central nervous system symptoms have not resolved and she can no longer fall asleep well. He stated that he was concerned that she was subjected to chemicals and that her symptoms have remained. He reported that she was treated with a cortisone shot and pills at the hospital and was given antihistamine tablets to take home. He described that she has drunk a lot of water and rested, but his concern is that the central nervous system symptoms are so new, and he is especially puzzled by how these sleep symptoms can stay. Product use was discontinued after the incident. The case outcome was improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that his wife had to be taken to the emergency room on (b)(6) 2016 because of extreme skin symptoms, itching and respiratory symptoms. He stated that they spent four hours at the emergency room clinic and that a cortisone shot was given at the emergency room as well as a cortisone and antihistamine cure as treatment. He reported that the skin symptoms continued for six days, and as a result of the poisoning there were central nervous system symptoms and sleeping difficulties, and he questioned how these will be treated. He stated that her skin symptoms were even more severe before the first aid. The case outcome remained improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that regarding his wife's situation they have been in contact with the healthcare center about melatonin and they told her to try it and that it is a very typical symptom when you ingest those kinds of chemicals - that you have trouble sleeping and you miss the deep sleeping phase. He stated that melatonin helps when you take two half milligram tablets. He reported that he has no doubt about what might have caused this. The case outcome remained improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that they went to first aid and his wife called the healthcare center contact person and told her of the case and received the instructions for melatonin. He stated that now they haven't gone anywhere, as it futile when you know what the chemical is and it serves no purpose to visit the healthcare center doctor. He described that what can be found online is something called chemical exposure and it's what has become active for her and they are hoping to make it go away somehow. He reported that they will try to have a look there again next week and then will have to see a specialized doctor. He stated that to date, they have only gone to the first aid healthcare center and that his wife is taking melatonin every night, a half hour before going to sleep. The case outcome remained improved. No further information was provided. On (b)(6) 2016 batch manufacturing records check completed: conclusion code: manufactured as intended based on investigation. Summary: the production lot code and product description was accurate and legitimate at the time of the intake call. Sap production planning and confirmation records confirmed that line (b)(4) produced brand code (b)(4) (alw ult rw 24x14sp prosp2 nord b3 nononm) with the process order (b)(4) on julian date ((b)(6)) (b)(6) 2016 at 02:44am. Quality reports passed quality assurance criteria to release and ship brand code (b)(4) to confirm that the product was manufactured as intended. The site quality alert system was searched for the production code identified and selected time frame before and after the production date and there were no quality events on that line. The line was running without any stops around the complaint time. Production records were reviewed and indicated the subject product was manufactured as intended without sent, and no deviations were observed. The quality check for scent free product after the change from scented product was passed to confirm that we produced as intended and on the same time to confirm that the onm pump is not in operation for a non scent product. The consumer stating that the accident coming from our scented product. The submitted production code from the complaint was product without any scent on the pad. An allergic reaction from scent on the product can be ruled out. The product was identified as always pads ultra base version wing regular-normal non deodorant upon record review. On (b)(6) 2016 consumer follow-up: the husband reported that his wife's situation has gotten a bit better and that about a week ago she woke up feeling like she had slept properly, for the first time. He stated that the situation is not yet normal, falling asleep takes longer and the deep sleep stage is still missing but it's getting better. The case outcome remained improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[60675685]
An accurate and legitimate lot number was provided by the reporter. Review of production records and quality reports concluded that the product was manufactured as intended based on investigation. The returned product has been received by the manufacturing plant and lab testing is underway.
Patient Sequence No: 1, Text Type: N, H10
[60675686]
Respiratory symptoms [respiratory disorder] chemical poisoning reaction - from the always ultra scented sanitary napkins [chemical poisoning] cortisone shot central nervous system symptoms [nervous system disorder] extreme skin symptoms [skin disorder] rash all over the body [rash generalised] headache [headache] sleeping difficulties/cannot sleep/problems sleeping [insomnia] itching [pruritus] chemical exposure - from the always ultra scented sanitary napkins [medical device site reaction] can no longer fall asleep well/falling asleep takes longer [initial insomnia] deep sleep stage is still missing [irregular sleep phase] strong allergic skin reaction [dermatitis allergic] case description: a husband reported on 30-aug-2016 via phone that his wife used always ultra pad beginning on an unknown date and she had a chemical poisoning reaction that included a rash all over her body and required that she be taken into the hospital. He described how they could not figure out what caused her symptoms at first, but then realized it started the same time as her menstrual period, on (b)(6) 2016. He stated that the reaction was so severe that his wife needed cortisone shots right away and that she then developed cortisone shot central nervous system symptoms, including a headache and difficulty sleeping, which have stayed. He reported that she is no longer in the hospital, that the rash lasted 3 days, but the central nervous system symptoms have not resolved and she can no longer fall asleep well. He stated that he was concerned that she was subjected to chemicals and that her symptoms have remained. He reported that she was treated with a cortisone shot and pills at the hospital and was given antihistamine tablets to take home. He described that she has drunk a lot of water and rested, but his concern is that the central nervous system symptoms are so new, and he is especially puzzled by how these sleep symptoms can stay. Product use was discontinued after the incident. The case outcome was improved. No further information was provided. On 30-aug-2016 consumer follow-up: the husband reported that his wife had to be taken to the emergency room on (b)(6) 2016 because of extreme skin symptoms, itching and respiratory symptoms. He stated that they spent four hours at the emergency room clinic and that a cortisone shot was given at the emergency room as well as a cortisone and antihistamine cure as treatment. He reported that the skin symptoms continued for six days, and as a result of the poisoning there were central nervous system symptoms and sleeping difficulties, and he questioned how these will be treated. He stated that her skin symptoms were even more severe before the first aid. The case outcome remained improved. No further information was provided. On 09-sep-2016 consumer follow-up: the husband reported that regarding his wife's situation they have been in contact with the healthcare center about melatonin and they told her to try it and that it is a very typical symptom when you ingest those kinds of chemicals - that you have trouble sleeping and you miss the deep sleeping phase. He stated that melatonin helps when you take two half milligram tablets. He reported that he has no doubt about what might have caused this. The case outcome remained improved. No further information was provided. On 9-sep-2016 consumer follow-up: the husband reported that they went to first aid and his wife called the healthcare center contact person and told her of the case and received the instructions for melatonin. He stated that now they haven't gone anywhere, as it futile when you know what the chemical is and it serves no purpose to visit the healthcare center doctor. He described that what can be found online is something called chemical exposure and it's what has become active for her and they are hoping to make it go away somehow. He reported that they will try to have a look there again next week and then will have to see a specialized doctor. He stated that to date, they have only gone to the first aid healthcare center and that his wife is taking melatonin every night, a half hour before going to sleep. The case outcome remained improved. No further information was provided. On 29-sep-2016 batch manufacturing records check completed: conclusion code: manufactured as intended based on investigation. Summary: the production lot code and product description was accurate and legitimate at the time of the intake call. (b)(4) to confirm that the product was manufactured as intended. The site quality alert system was searched for the production code identified and selected time frame before and after the production date and there were no quality events on that line. The line was running without any stops around the complaint time. Production records were reviewed and indicated the subject product was manufactured as intended without sent, and no deviations were observed. The quality check for scent free product after the change from scented product was passed to confirm that we produced as intended and on the same time to confirm that the onm pump is not in operation for a non scent product. The consumer stating that the accident coming from our scented product. The submitted production code from the complaint was product without any scent on the pad. An allergic reaction from scent on the product can be ruled out. The product was identified as always pads ultra base version wing regular-normal non deodorant upon record review. On 12-oct-2016 consumer follow-up: the husband reported that his wife's situation has gotten a bit better and that about a week ago she woke up feeling like she had slept properly, for the first time. He stated that the situation is not yet normal, falling asleep takes longer and the deep sleep stage is still missing but it's getting better. The case outcome remained improved. No further information was provided. On 03-nov-2016 translation of consumer questionnaire received 28-oct-2016: a (b)(6) female consumer reported using always pads ultra base version wing regular-normal non deodorant for the first time for menstruation, one pad, beginning either (b)(6) 2016 and 10 hours later experienced a strong allergic skin reaction and problems sleeping. She visited a physician and was treated with a cortisone injection and an antihistamine as well as first aid at the clinic and was prescribed tavor. She described that presently she is suffering from problems/difficulty sleeping, deep sleep. She stated that her symptoms lasted 8 days. She reported that her sleep symptoms had not resolved. She did not try using always ultra again. Relevant history: allergy-none; drug allergy-none; medical history-not presently or within last 6 months suffering from other diseases; concomitant products-none. She reported that she had no had any problems with other products in the past. The case outcome remained improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[64025934]
An accurate and legitimate lot number was provided by the reporter. Review of production records and quality reports concluded that the product was manufactured without scent as intended based on investigation. The returned product was received by the manufacturing plant. A visual check of the returned product as well as analytical testing concluded that the content of preservatives and allergenic fragrances was below the limit of detection.
Patient Sequence No: 1, Text Type: N, H10
[64025935]
Respiratory symptoms [respiratory disorder]. Chemical poisoning reaction - from the always ultra scented sanitary napkins [chemical poisoning]. Cortisone shot central nervous system symptoms [nervous system disorder]. Extreme skin symptoms [skin disorder]. Rash all over the body [rash generalised]. Headache [headache]. Sleeping difficulties/cannot sleep/problems sleeping [insomnia]. Itching [pruritus]. Chemical exposure - from the always ultra scented sanitary napkins [medical device site reaction]. Can no longer fall asleep well/falling asleep takes longer [initial insomnia deep sleep stage is still missing [irregular sleep phase]. Strong allergic skin reaction [dermatitis allergic]. Sleeping disorder/jolted awake in the middle of the night [sleep disorder]. Case description: a husband reported on (b)(6) 2016 via phone that his wife used always ultra pad beginning on an unknown date and she had a chemical poisoning reaction that included a rash all over her body and required that she be taken into the hospital. He described how they could not figure out what caused her symptoms at first, but then realized it started the same time as her menstrual period, on (b)(6) 2016. He stated that the reaction was so severe that his wife needed cortisone shots right away and that she then developed cortisone shot central nervous system symptoms, including a headache and difficulty sleeping, which have stayed. He reported that she is no longer in the hospital, that the rash lasted 3 days, but the central nervous system symptoms have not resolved and she can no longer fall asleep well. He stated that he was concerned that she was subjected to chemicals and that her symptoms have remained. He reported that she was treated with a cortisone shot and pills at the hospital and was given antihistamine tablets to take home. He described that she has drunk a lot of water and rested, but his concern is that the central nervous system symptoms are so new, and he is especially puzzled by how these sleep symptoms can stay. Product use was discontinued after the incident. The case outcome was improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that his wife had to be taken to the emergency room on (b)(6) 2016 because of extreme skin symptoms, itching and respiratory symptoms. He stated that they spent four hours at the emergency room clinic and that a cortisone shot was given at the emergency room as well as a cortisone and antihistamine cure as treatment. He reported that the skin symptoms continued for six days, and as a result of the poisoning there were central nervous system symptoms and sleeping difficulties, and he questioned how these will be treated. He stated that her skin symptoms were even more severe before the first aid. The case outcome remained improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that regarding his wife's situation they have been in contact with the healthcare center about melatonin and they told her to try it and that it is a very typical symptom when you ingest those kinds of chemicals - that you have trouble sleeping and you miss the deep sleeping phase. He stated that melatonin helps when you take two half milligram tablets. He reported that he has no doubt about what might have caused this. The case outcome remained improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the husband reported that they went to first aid and his wife called the healthcare center contact person and told her of the case and received the instructions for melatonin. He stated that now they haven't gone anywhere, as it futile when you know what the chemical is and it serves no purpose to visit the healthcare center doctor. He described that what can be found online is something called chemical exposure and it's what has become active for her and they are hoping to make it go away somehow. He reported that they will try to have a look there again next week and then will have to see a specialized doctor. He stated that to date, they have only gone to the first aid healthcare center and that his wife is taking melatonin every night, a half hour before going to sleep. The case outcome remained improved. No further information was provided. On 29-sep-2016 batch manufacturing records check completed: conclusion code: manufactured as intended based on investigation. Summary: the production lot code and product description was accurate and legitimate at the time of the intake call. Sap production planning and confirmation records confirmed that line 19 produced brand code 83731050 (alw ult rw 24x14sp prosp2 nord b3 nononm) with (b)(4) on julian date (6045) february 15th 2016 at 02:44am. Quality reports passed quality assurance criteria to release and ship brand code 83731050 to confirm that the product was manufactured as intended. The site quality alert system was searched for the production code identified and selected time frame before and after the production date and there were no quality events on that line. The line was running without any stops around the complaint time. Production records were reviewed and indicated the subject product was manufactured as intended without sent, and no deviations were observed. The quality check for scent free product after the change from scented product was passed to confirm that we produced as intended and on the same time to confirm that the onm pump is not in operation for a non scent product. The consumer stating that the accident coming from our scented product. The submitted production code from the complaint was product without any scent on the pad. An allergic reaction from scent on the product can be ruled out. The product was identified as always pads ultra base version wing regular-normal non deodorant upon record review. On (b)(6) 2016 consumer follow-up: the husband reported that his wife's situation has gotten a bit better and that about a week ago she woke up feeling like she had slept properly, for the first time. He stated that the situation is not yet normal, falling asleep takes longer and the deep sleep stage is still missing but it's getting better. The case outcome remained improved. No further information was provided. On 03-nov-2016 translation of consumer questionnaire received 28-oct-2016: a (b)(6) female consumer reported using always pads ultra base version wing regular-normal non deodorant for the first time for menstruation, one pad, beginning either (b)(6) 2016 or (b)(6) 2016 through (b)(6) 2016 and 10 hours later experienced a strong allergic skin reaction and problems sleeping. She visited a physician and was treated with a cortisone injection and an antihistamine as well as first aid at the clinic and was prescribed tavor. She described that presently she is suffering from problems/difficulty sleeping, deep sleep. She stated that her symptoms lasted 8 days. She reported that her sleep symptoms had not resolved. She did not try using always ultra again. Relevant history: allergy-none; drug allergy-none; medical history-not presently or within last 6 months suffering from other diseases; concomitant products-none. She reported that she had no had any problems with other products in the past. The case outcome remained improved. No further information was provided. On 30-nov-2016 update - translation of medical invoice received by consumer relations on 23-nov-2016: the consumer visited an on-call (b)(6) on (b)(6) 2016 and was charged with a general on-call fee. No further information was provided. On (b)(6) 2016 received consumer follow-up: the husband reported that his wife's symptoms have gone in a better direction, so that sometimes she takes the melatonin, which she hasn't needed at all before. He stated that for a long time she had a sleeping disorder and that she is still jolted awake in the middle of the night, which isn't normal, but is out of the ordinary. He reported that it is, however, headed in a better direction. The case outcome remained improved. No further information was provided. On 02-jan-2017 product investigation completed: conclusion code: manufactured as intended based on investigation. Summary: l1 investigation 16 december 2016 with returned pad. The team concludes the following, to close the investigation: on the returned pad visible check we didn`t see any issue what caused an allergic reaction. As second step was that we sent the returned pads together with current production pads to an analytical lab to check the pads for allergenic fragrances, preservatives and metal inside the pad. The content of preservatives and allergenic fragrances is in both samples below the limit of detection. The analyzed content of metal in the consumer complaint and in the current production shows a similar concentration. Please see the detailed checked parameter. No further action is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680085-2016-00002 |
| MDR Report Key | 5987073 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2016-09-29 |
| Date of Report | 2016-08-30 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2016-09-29 |
| 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 FEMININE CARE |
| Manufacturer Street | 6110 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE |
| Manufacturer Street | P&G STRASSE 1 D-74564 |
| Manufacturer City | CRAILSHEIM, D-7180 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-7180 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSPADSULTRAULTRABASEVERWINGREGNORNONDO |
| Generic Name | PAD, MENSTRUAL, SCENTED |
| Product Code | HHL |
| Date Received | 2016-09-29 |
| Returned To Mfg | 2016-11-18 |
| Lot Number | 6 045 0314 19 02 : 44 D 140216 |
| 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 | PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE |
| Manufacturer Address | P&G STRASSE 1 D-74564 CRAILSHEIM, D-7180 GM D-7180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-29 |