MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for ALWAYS DISCREET, MODERATE 4. LONG LENGTH manufactured by Procter & Gamble Gmbh & Co., Manufacturing Ohe.
[121742427]
After wearing always discreet pads for 6 hours, i had to remove the pad due to severe itch. These symptoms have continued into the next day. I had previously used these pads and developed severe itch and irritation, but had not made the connection to the use of the pads. That event lasted 2 weeks until the symptoms subsided. During that time i tried using several topical creams and powders to provide relief. Dates of use: (b)(6) 2018. Reason for use: bladder incontinence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080080 |
| MDR Report Key | 7905773 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-23 |
| Date of Event | 2018-09-22 |
| Date Added to Maude | 2018-09-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALWAYS DISCREET, MODERATE 4. LONG LENGTH |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-09-24 |
| Lot Number | 8133478600 58 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE GMBH & CO., MANUFACTURING OHE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-24 |