MAUDE Adverse Event Report: CHURCH & DWIGHT COMPANY, INC. REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER

Lot Number UF 8001C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101); Urinary Frequency (2275); Hematuria (2558)

Event Date 07/12/2018

Event Type  Injury  

Event Description

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.

• Brand Name: REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
• Type of Device: REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
• Manufacturer (Section D): CHURCH & DWIGHT COMPANY, INC.
• MDR Report Key: 7697620
• MDR Text Key: 114364127
• Report Number: MW5078429
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/01/2020
• Device Lot Number: UF 8001C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR