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 Number: MW5078429
• MDR Report Key: 7697620
• Date Received: 2018-07-17
• Date of Report: 2018-07-15
• Date of Event: 2018-07-12
• Date Added to Maude: 2018-07-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
• Generic Name: REPLENS MOISTURIZER LONG LASTING VAGINAL MOISTURIZER
• Product Code: NUC
• Date Received: 2018-07-17
• Lot Number: UF 8001C
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHURCH & DWIGHT COMPANY, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-07-17