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