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

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123); Discomfort (2330)

Event Date 12/18/2021

Event Type  Injury  

Event Description

I used replens long-lasting vaginal moisturizer lubricant again after trying previously.While the product did reduce my itching, i had a very large amount of clumpy white discharge which was stuck inside my vagina.The volume was large enough to be uncomfortable, and it was difficult to remove.Since my skin is already delicate, i experienced some minor bleeding after trying to clean out the replens.Vaginal pain and itching.

• Brand Name: REPLENS LONG-LASTING VAGINAL MOISTURIZER LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 13059929
• MDR Text Key: 282640220
• Report Number: MW5106204
• 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: 12/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM; CELEXA; FEMRING; SUMATRIPTAN ; VITAMINS ; WELLBUTRIN
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White