MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-03-06 for K-Y BRAND LIQUID PERSONAL manufactured by Personal Products Co..
[16726340]
Consumer reported product caused vaginal burning and vaginal pain after use and caused first and second-degree burns and scarring. Consumer stated symptoms are abating but she is still uncomfortable as she has been treating reactions for 11 months and they have not gone away. Consumer states she used product in (b)(6) 2005. Immediately experienced vaginal burning and pain. Removed product and burning increased. Contacted hcp. Consumer states patches of pubic hair are also falling out. Advised consumer to discontinue use and contact hcp as needed. Contacted consumer to obtain additional information regarding alleged reaction. Consumer stated she applied the product once for the use of intercourse due to pain.
Patient Sequence No: 1, Text Type: D, B5
[17083041]
Since no product was returned, a retain sample was tested and conformed to the product specification. The retain batch record were reviewed and no defects were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2006-00004 |
| MDR Report Key | 2667093 |
| Report Source | 04 |
| Date Received | 2006-03-06 |
| Date of Report | 2006-03-06 |
| Date of Event | 2005-02-01 |
| Date Mfgr Received | 2006-02-07 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2012-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Street | 199 GRANDVIEW RD. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y BRAND LIQUID PERSONAL |
| Generic Name | PERSONAL LUBRICANT KMJ |
| Product Code | KMJ |
| Date Received | 2006-03-06 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 1984C |
| ID Number | NA |
| Device Expiration Date | 2006-06-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERSONAL PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-06 |