MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-12-18 for K-Y BRAND SENSUAL SILK WARMING manufactured by Mcneil-ppc, Inc.
[15005003]
Consumer reported burning sensation, raised rash, blisters in vaginal area. Symptoms abating. Contacted healthcare provider. Treatment of valtrex.
Patient Sequence No: 1, Text Type: D, B5
[15522492]
No valid lot number was provided. A review of the complaint data revealed no significant adverse trends for complaints of this nature involving this product. Complaint trends will continue to be monitored.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2008-00012 |
| MDR Report Key | 1269859 |
| Report Source | 04 |
| Date Received | 2008-12-18 |
| Date of Report | 2008-12-18 |
| Date of Event | 2008-11-14 |
| Date Mfgr Received | 2008-11-21 |
| Date Added to Maude | 2009-01-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 199 GRANDVIEW RD. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741000 |
| Manufacturer G1 | KIK CUSTOM PRODUCTS |
| Manufacturer Street | 13 BETHRIDGE ROAD |
| Manufacturer City | ETOBICOKE, ONTARIO M9W1M6 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M9W1M6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y BRAND SENSUAL SILK WARMING |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | KMJ |
| Date Received | 2008-12-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| 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 | MCNEIL-PPC, INC |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08551 US 08551 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-18 |