MAUDE Adverse Event Report: CHURCH & DWIGHT CO. REPLENS LONG LASTING VAGINAL MOISTURIZER

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 07/15/2016

Event Type  Injury  

Event Description

After using this product, i first experienced white cottage cheese discharge which was to be expected but then it turned into black coal like lumps.I started bleeding between periods and developed burning and itching.On a visit to my gynecologist, she had to remove clumps of the product before the exam could take place.Much of it was removed but some still remained.Experience, bloating and pelvic pain.Still passing black coal like lumps even though i haven't used the product in over two months.Dates of use: (b)(6) 2016.Diagnosis or reason for use: vaginal dryness.

• Brand Name: REPLENS LONG LASTING VAGINAL MOISTURIZER
• Type of Device: REPLENS LONG LASTING VAGINAL MOISTURIZER
• Manufacturer (Section D): CHURCH & DWIGHT CO.
• MDR Report Key: 5895867
• MDR Text Key: 52856647
• Report Number: MW5064245
• Device Sequence Number: 1
• Product Code: NUC
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 81