MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for YOURS AND MINE KY manufactured by .
[38863126]
Ky vaginal products appears to have caused burns and blisters for women using the product "yours and mine," and possibly others. I noticed (b)(6) four women complained that the product resulted in burning, and two said the product gave them internal blisters. One woman though it was from menthol in the product. I thought the fda might be interested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060423 |
| MDR Report Key | 5455015 |
| Date Received | 2016-02-18 |
| Date of Report | 2016-02-18 |
| Date of Event | 2016-02-18 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | YOURS AND MINE KY |
| Generic Name | YOURS AND MINE KY |
| Product Code | NUC |
| Date Received | 2016-02-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-18 |