MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-02 for K-Y WARMING SENSATION manufactured by .
[44562945]
I used ky warming lube and had this really bad burning occur. A few days after i used it i noticed i couldn't walk and i had bumps inside and around my vulva, like how they would describe herpes to be.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062098 |
| MDR Report Key | 5633767 |
| Date Received | 2016-05-02 |
| Date of Report | 2016-05-02 |
| Date of Event | 2016-04-28 |
| Date Added to Maude | 2016-05-05 |
| 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 | K-Y WARMING SENSATION |
| Generic Name | K-Y WARMING SENSATION |
| Product Code | KMJ |
| Date Received | 2016-05-02 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-02 |