REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER manufactured by Church & Dwight Company, Inc..

Event Text Entries

[114364127] Used replens as directed on sunday evening and again on wednesday evening. Next day thursday i started experiencing bladder fullness, feeling as if i had to urine every 5 mins or so. Each time i would fill the toilet bowl with red blood to include blood clots. This sent on for a full 12 hrs at which time i then stopped bleeding and a few hours after that i felt my bladder start going back to normal. During those 12 hrs, i experienced lack of bladder control. When i thought about urinating, i barely made it to toilet. I am 5 yrs post menopausal with no history of bleeding. I do not take hormone replacement or use any estrogen. I had a complete gyno checkup 4 wks and no problems. It was the result of the replen. Not just spotting but full bleeding like before menopause. On that thursday i called replens medical hotline. They told me that this bleeding was not a side effect and no one else had reported that side effect. I cannot believe i am the only person to experience this. I also do not take any prescription medicines. I believe this side effect should be investigated and reported as a possible side effect to this over the counter drug. "how was it used: vaginal. " dates of use: (b)(6) 2018 - (b)(6) 2018. Reason for use: vaginal dryness.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078429
MDR Report Key7697620
Date Received2018-07-17
Date of Report2018-07-15
Date of Event2018-07-12
Date Added to Maude2018-07-18
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 Report3

Device Details

Brand NameREPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
Generic NameREPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
Product CodeNUC
Date Received2018-07-17
Lot NumberUF 8001C
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHURCH & DWIGHT COMPANY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-17

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