REPLENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for REPLENS manufactured by Church And Dwight.

Event Text Entries

[92977735] Since my wife experiences painful sex, we used the personal lubricant named replens topically with the amount of about a nickel on my two fingers and then applied just inside her vagina. The next day i started to feel some irritation inside the shaft of my penis. The second day the irritation was much worse. Burning and irritation with urination, shooting sharp pains in the shaft of my penis. The pain in my intestines, lower back, near my heart and upper left arm, and in my temples and other parts of my body. The nurse convinced me to see a urologist which i did finally see on (b)(6). He took another urine sample and provided me with a scope hooked up to a computer screen. He saw no obstructions. Had rock like bowel movements. Pains in my left upper shoulder, alongside my left breast and in the breast, pain and pressure in the left side and right side of my neck and numerous other pains in my toes, legs, etc. Replens is ruining my life both physically and psychologically. It had caused both physical and mental torture. Replens has caused many sleepless nights because of the pain it has and is still inflicting on me.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073556
MDR Report Key7057505
Date Received2017-11-24
Date of Report2017-11-21
Date of Event2016-07-01
Date Added to Maude2017-11-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREPLENS
Generic NamePERSONAL LUBRICANT
Product CodeNUC
Date Received2017-11-24
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHURCH AND DWIGHT


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-24

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