MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for KY WARMING LIQUID manufactured by Reckit Bankiser.
[66913056]
My wife recently bought a new vaginal lubricant ky warming liquid. After using it the first time i developed a painful rash on my penis. My wife had no ill effects so far. I am (b)(6) and did not wear a condom. I am being treated by antifungal pills and creams, but no improvement so far. I noted several similar complaints in the internet. Please be aware of this problem. Why was the person using the product: sexual aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067728 |
| MDR Report Key | 6311374 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-04 |
| Date of Event | 2017-01-21 |
| Date Added to Maude | 2017-02-08 |
| 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 | KY WARMING LIQUID |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-02-06 |
| Lot Number | 28561 |
| Device Expiration Date | 2018-01-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKIT BANKISER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |