FDA Adverse Event
Injury
Summary report: N
K-Y YOUR'S AND MINE COUPLES LUBRICANT
MDR report key: 1515952
·
Received October 23, 2009
Report
- Report Number
- 2214133-2009-00011
- Event Type
- Injury
- Date Received
- October 23, 2009
- Report Date
- October 6, 2009
- 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 ADD'L, SIGNIFICANT INFO IS REC'D. REPORT SENT TO FDA ON 10/23/2009.
Description of Event or Problem · 1
THE CUSTOMER IS ALLERGIC TO MENTHOL AND USED THIS PRODUCT AND EXPERIENCED VAGINAL AND VAGINAL BLISTERS. WAS TREATED WITH A VAGINAL CREAM BY HER PHYSICIAN. SYMPTOMS ARE ABATING. ADVISED TO DISCONTINUE USE AND FOLLOW-UP WITH HER PHYSICIAN AS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-Y YOUR'S AND MINE COUPLES LUBRICANT | PERSONAL LUBRICANT | NUC | MCNEIL-PPC, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | ATENALOAL |