FDA Adverse Event
Injury
Summary report: N
REPLENS PERSONAL LUBRICANT
MDR report key: 20795101
·
Received November 26, 2024
Report
- Report Number
- MW5162899
- Event Type
- Injury
- Date Received
- November 26, 2024
- Date of Event
- October 12, 2024
- Report Date
- November 21, 2024
- Manufacturer
- CHURCH & DWIGHT CO, INC.
- Product Code
- NUC
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PER ADVERTISING I TRIED REPLENS PERSONAL LUBRICANT. I ALSO TRIED IT A SECOND TIME WAITING TO BE SURE OTHER FACTORS WERE NOT IN PLAY. BOTH TIMES, USING PRODUCT AS DIRECTED (ONE APPLICATION EVERY THREE DAYS). EVERY APPLICATION BROUGHT ON SIDE EFFECTS (VAGINAL YEAST INFECTION, VAGINAL OR BLADDER SPASMS; PAINFUL URINATION, PAINFUL VAGINAL LINING, VERY PAINFUL SEX). BEFORE TRYING THE SECOND BOX I WAITED UNTIL THESE PROBLEMS WENT AWAY. THEY DID 2-4 WKS AFTER STOPPING PRODUCT USE AND TREATING YEAST INFECTION WITH FLUCONAZOLE AND THE BLADDER PROBLEMS WITH AZO TWICE DAILY FOR 10 DAYS. UPON TRYING REPLENS AGAIN, I EXPERIENCED THE SAME SIDE EFFECTS. REF REPORT: MW5162900.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831430 | REPLENS PERSONAL LUBRICANT | LUBRICANT, PERSONAL | NUC | CHURCH & DWIGHT CO, INC. | KK411507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | CBD GELS | CELEBREX| DIGESTIVE | ENZYMES | PROBIOTICS| SYNTHROID| VIT C | VIT D3 |