FDA Adverse Event
Injury
Summary report: N
K-Y BRAND LIQUID
MDR report key: 1212565
·
Received October 24, 2008
Report
- Report Number
- 2214133-2008-00008
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 24, 2008
- Manufacturer
- CONSUMER HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC.
- Product Code
- NUC
- PMA / PMN Number
- K955648
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A RETURNED SAMPLE HAS NOT BEEN RECEIVED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO SIGNIFICANT ADVERSE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.
Description of Event or Problem · 1
CONS STATED SHE USED PRODUCT FOR INTERCOURSE AND HAS DEVELOPED SEVERAL BLADDER INFECTIONS SINCE 2008. SHE SAW HER DOCTOR, AND IS UNDERGOING TREATMENT. SYMPTOMS HAVE NOT ABATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-Y BRAND LIQUID | PERONAL LUBRICANT | NUC | CONSUMER HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, INC. | NA | 1427C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |