MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for STAYFREE ULTRA THIN PADS WITH WINGS (18 CT) manufactured by Playtex Manufacturing Inc.
[136006043]
Rash developed in the area that made contact with sanitary pad. The problem stopped after the person stopped using the product. The problem returned if the person started using the product. Person started using the product on (b)(6) 2018. Person stopped using the product (b)(6) 2018. The person was using the product for menstruation. Product use: topical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083814 |
| MDR Report Key | 8315627 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-12-22 |
| Date Added to Maude | 2019-02-07 |
| 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 |
| 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 | STAYFREE ULTRA THIN PADS WITH WINGS (18 CT) |
| Generic Name | PAD MENSTRUAL UNSCENTED |
| Product Code | HHL |
| Date Received | 2019-02-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-06 |