REPLENS VAGINAL MOISTURIZER 1.23 OZ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for REPLENS VAGINAL MOISTURIZER 1.23 OZ manufactured by Church And Dwight Co., Inc..

Event Text Entries

[40033327] At the recommendation of my personal md, i started using replens vaginal moisturizer. I used it twice, exactly as instructed in the product brochure. The second application was 4 days after irritation and bleeding! I am (b)(6) and went through menopause 5 years ago. I have had no bleeding since menopause until this event. Dose or amount: 1/14 if 1. 23 oz every 3 days or as vaginal. Dates of use: (b)(4) 2016. Diagnosis or reason for use: vaginal dryness. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060796
MDR Report Key5489918
Date Received2016-03-04
Date of Report2016-03-04
Date of Event2016-03-03
Date Added to Maude2016-03-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 VAGINAL MOISTURIZER 1.23 OZ
Generic NameREPLENS VAGINAL MOISTURIZER 1.23 OZ
Product CodeNUC
Date Received2016-03-04
Lot NumberUF5280
Device Expiration Date2018-10-01
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCHURCH AND DWIGHT CO., INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-04

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