FDA Adverse Event
Injury
Summary report: N
KY YOURS AND MINE COUPLES LUBRICANT
MDR report key: 1612451
·
Received February 17, 2010
Report
- Report Number
- 2214133-2010-00001
- Event Type
- Injury
- Date Received
- February 17, 2010
- Date of Event
- January 25, 2010
- Report Date
- January 25, 2010
- Manufacturer
- MCNEIL, PPC INC.
- Product Code
- NUC
- PMA / PMN Number
- K072421
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
Description of Event or Problem · 1
CONSUMER ALLEGES THIRD DEGREE BURNS AND MAJOR INFECTION FOLLOWING THE USE OF THE PRODUCT, NECESSITATING UNCONFIRMED MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO THE APPLICATION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KY YOURS AND MINE COUPLES LUBRICANT | PERSONAL LUBRICANT | NUC | MCNEIL, PPC INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |