MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2012-09-26 for ALWAYS/ALLDAYS PANTYLINER, SCENTED (NOT APPLICABLE N/A) LINER 1APPLIC manufactured by Procter & Gamble Gmbh & Co..
[2907923]
Severe allergic reaction [hypersensitivity]. Irritation [skin irritation]. Rash [rash]. Pain [pain]. Injury [injury]. Case description: a consumer reported that they, an adult female age unspecified, used always/alldays pantyliner, large scented liner by mistake, unspecified total daily use, and reported the following: severe allergic reaction, irritation, rash, pain, injury. The consumer was hospitalized in the gynecology ward and discharged on (b)(6) 2012. She visited her doctor and discontinued use of the product. The case outcome was unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[10139399]
Batch number and product samples were provided by the reporter. Batch retains investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680085-2012-00001 |
| MDR Report Key | 2764241 |
| Report Source | 00,01,04 |
| Date Received | 2012-09-26 |
| Date of Report | 2012-07-02 |
| Date Mfgr Received | 2012-07-02 |
| Date Added to Maude | 2012-10-01 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HILL BUSINESS CENTER |
| 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 |
| Manufacturer City | CRAILSHEIM 74564 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 74564 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS/ALLDAYS PANTYLINER, SCENTED (NOT APPLICABLE N/A) LINER 1APPLIC |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2012-09-26 |
| Lot Number | 2084031435B1614D240312 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2012-09-26 |