MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2014-07-01 for ALWAYS/NATURELLA/ORKID/ONLY YOU PAD, SCENTED manufactured by Procter & Gamble Gmbh & Co..
[4631396]
Eczema on genital skin - female [eczema]. Rash-vagina [vulvovaginal rash]. Case description: a consumer reported that they, a female age unspecified, used always pads ultra actipearls wing regular normal 1 applic, daily beginning (b)(6) 2013 and reported the following: eczema on female genital skin and vaginal rash. The consumer was admitted to the hospital for 2 weeks. Treatment: cortisone, ointment. The case outcome was not recovered/not resolved. The consumer was advised to discontinue use of the product but she continued to use the always pads. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[12069555]
A lot number was provided by the reporter, lot check and batch retain testing pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680085-2014-00001 |
| MDR Report Key | 3975147 |
| Report Source | 01,04 |
| Date Received | 2014-07-01 |
| Date of Report | 2014-05-30 |
| Date Mfgr Received | 2014-05-30 |
| Date Added to Maude | 2014-08-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MGR. |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HILL BUSINESS CENTER |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | HYGINETT HUNGARIAN AMERICAN CO |
| Manufacturer Street | HATAR U.3 |
| Manufacturer City | CSOMOR 2141 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS/NATURELLA/ORKID/ONLY YOU PAD, SCENTED |
| Generic Name | NONE |
| Product Code | HHL |
| Date Received | 2014-07-01 |
| Lot Number | 32710314191435 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE GMBH & CO. |
| Manufacturer Address | CRAILSHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2014-07-01 |