MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. REPLENS LONG LASTING VAGINAL LUBRICANT

Lot Number	UF5280
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Used replens vaginal moisturizer by first response and about 6 hours later noticed i had pelvic pain.Though i might be ovulating (b)(6) so didn't make the connection right away.The next day i still had discomfort with a new symptom of bladder pain and pressure.By the 3rd day i knew my symptoms were from using this product.I then went on webmd to research this product and found out it indeed has bladder side effects.This totally bites! now it's friday (b)(6), and my symptoms are worse.I'm researching what to do for a bladder ache.Dose or amount (ies): every 3 hours, route: vaginal.Reason for use: vaginal dryness.

• Brand Name: REPLENS LONG LASTING VAGINAL LUBRICANT
• Common Device Name: REPLENS LONG LASTING VAGINAL LUBRICANT
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 5808307
• Report Number: MW5063511
• Device Sequence Number: 12615611
• Product Code: NUC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UF5280
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 54