MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-10-07 for ALWAYSLNR manufactured by Procter & Gamble Gmbh & Co. Manufacturing Ohe.
[56791217]
The reporter informed the company that the product has been discarded.
Patient Sequence No: 1, Text Type: N, H10
[56791218]
Infection in vaginal area [vaginal infection]. Really burns-vagina and all the labia [vulvovaginal burning sensation]. Always liner had fragrance/package does not indicate a scent [product odour abnormal]. Case description: an adult female consumer reported via phone on (b)(6) 2016 using always liner for the first time beginning on an unspecified date, 1 liner every two hours (5-6 times a day) and a week ago got a serious infection in her vaginal area as well as burning to her vagina and labia. She stated that she visited a gynecologist at a clinic who recommended/prescribed antibiotics, ointments (agisten) and small red pills (does not remember what it is called) but her condition is getting worse. She reported that she was currently on her way to the emergency room. She described that she always uses always, but ever since the new series there is a problem, and by mistake she bought always with fragrance. Product use was discontinued this morning. Relevant history: allergy to fragrances. The case outcome was not recovered/not resolved. No further information was provided. On 11-sep-2016 consumer follow-up: the consumer reported that she has had problems up until now, that she was in the hospital and the antibiotic they gave her did not help and she even went to a private physician. The case outcome remained not recovered/not resolved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[58622225]
The reporter informed the company that the product has been discarded.
Patient Sequence No: 1, Text Type: N, H10
[58622226]
Infection in vaginal area [vaginal infection]; really burns-vagina and all the labia [vulvovaginal burning sensation]; always liner had fragrance/package does not indicate a scent [product odour abnormal]. Case description: an adult female consumer reported via phone on (b)(6) 2016 using (b)(6) liner for the first time beginning on an unspecified date, 1 liner every two hours (5-6 times a day) and a week ago got a serious infection in her vaginal area as well as burning to her vagina and labia. She stated that she visited a gynecologist at a clinic who recommended/prescribed antibiotics, ointments (agisten) and small red pills (does not remember what it is called) but her condition is getting worse. She reported that she was currently on her way to the emergency room. She described that she always uses (b)(6), but ever since the new series there is a problem, and by mistake she bought always with fragrance. Product use was discontinued this morning. Relevant history: allergy to fragrances. The case outcome was not recovered/not resolved. No further information was provided. On (b)(6) 2016 consumer follow-up: the consumer reported that she has had problems up until now, that she was in the hospital and the antibiotic they gave her did not help and she even went to a private physician. The case outcome remained not recovered/not resolved. No further information was provided. On (b)(6) 2016 consumer follow-up: the consumer reported that she used (b)(6) pads size large and was hospitalized for 3 days for her symptoms and thinks that she received antibiotics. She stated that she had symptoms for another week. The case outcome was recovered. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022168-2016-00003 |
| MDR Report Key | 6010460 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-10-07 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-10-16 |
| Date Added to Maude | 2016-10-07 |
| 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 | ALWAYSLNR |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2016-10-07 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Other | 2016-10-07 |