MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-04-29 for K-Y JELLY PERSONAL LUBRICANT manufactured by J&j Healthcare Products Div Mcneil-ppc, Inc..
[2752228]
On (b)(6) 2010, the consumer indicated that he recently found a bottle of ky jelly in his medicine cabinet and not knowing it was 4 years old, used it. The consumer called again on (b)(6) 2010 and claimed the product gave him (b)(6). He checked the (b)(6) of his penis and it has little pimples on it.
Patient Sequence No: 1, Text Type: D, B5
[9808596]
Date of this submission is (b)(4) 2010. This closes out this report unless additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2010-00006 |
| MDR Report Key | 2560038 |
| Report Source | 04 |
| Date Received | 2010-04-29 |
| Date of Report | 2010-03-18 |
| Date Mfgr Received | 2010-03-18 |
| Date Added to Maude | 2012-05-07 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH TUREK |
| Manufacturer Street | 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y JELLY PERSONAL LUBRICANT |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | KMJ |
| Date Received | 2010-04-29 |
| 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 | J&J HEALTHCARE PRODUCTS DIV MCNEIL-PPC, INC. |
| Manufacturer Address | 199 GRANDVIEW RD SKLLIMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-29 |