MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-25 for ALWAYSPADS manufactured by Procter & Gamble Gmbh & Co. Manufacturing Ohe.
[41224961]
Return of product has been requested. Product and lot number was not provided by reporter therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of returned product. This (b)(6) always pad adverse event case likely involves a product manufactured at any one of four procter & gamble plants located in: (b)(4). Since the always pad product involved in this case is similar to that sold in the us, and since only one of these sites has an active medical device establishment number, we will be submitting this case under (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41224962]
Skin peeling off vagina [vaginal exfoliation] rash-vagina [vulvovaginal rash] case description: a mother reported that her (b)(6) year old adult daughter used always pads, unknown version, use and frequency, and her daughter developed a rash in her vaginal area so badly that her skin was peeling off and she has been admitted to the hospital. Treatment details were unknown. The case outcome was not recovered/not resolved. Relevant medical history: none reported. Concomitant product(s): none reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680085-2016-00001 |
| MDR Report Key | 5527261 |
| Date Received | 2016-03-25 |
| Date of Report | 2016-02-25 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-03-25 |
| 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 INC |
| Manufacturer Street | 365 UNIVERSITY AVE |
| Manufacturer City | BELLEVILLE, ON K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALWAYSPADS |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2016-03-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-03-25 |