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 TOUCH MASSAGE 2-IN-1 WARMING manufactured by Mcneil-ppc, Inc..
[1000172]
Applied to genitals and developed burning, redness and blisters filled with pus on genitals.
Patient Sequence No: 1, Text Type: D, B5
[8246932]
A review of the data associated with this complaint category revealed no significant adverse trends and no trend involving this lot number. Complaint trends will continue to be monitored. The retain sample was examined and presented a quality appearance for both packaging and product. The retain sample was tested for: appearance-meets spec. Viscosity - meets spec. Odor - meets spec. Condition of container - meets spec. Batch records were reviewed, and no defects were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2008-00009 |
| MDR Report Key | 1269856 |
| Report Source | 04 |
| Date Received | 2008-12-18 |
| Date of Report | 2008-12-18 |
| Date of Event | 2008-11-10 |
| Date Mfgr Received | 2008-11-11 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-01-13 |
| 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 08551 |
| Manufacturer Country | US |
| Manufacturer Postal | 08551 |
| 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 TOUCH MASSAGE 2-IN-1 WARMING |
| Generic Name | BODY MASSAGE + PERSONAL LUBRICANT |
| Product Code | KMJ |
| Date Received | 2008-12-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 0297C |
| ID Number | NA |
| Device Expiration Date | 2009-11-01 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-18 |