MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for STAYFREE SUPER MAXIPAD manufactured by Johnson And Johnson/ Playtex.
[109236401]
Patient's husband purchased stayfree maxipad on (b)(6) and his wife has used the product for 4 days. On the 4th day, patient experienced severe pain, redness, irritation and swelling on bilateral thigh and labia. She has not seen physician due to fear and apprehension of doctors as well as no medical insurance. All symptoms have decreased, but has not completely gone away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077434 |
| MDR Report Key | 7540474 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-04-18 |
| Date Added to Maude | 2018-05-24 |
| 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 | STAYFREE SUPER MAXIPAD |
| Generic Name | MAXIPAD |
| Product Code | HHD |
| Date Received | 2018-05-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON/ PLAYTEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-23 |