MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. REPLENS; LUBRICANT, PERSONAL

Lot Number KK30930

Patient Problem Abdominal Cramps (2543)

Event Date 08/24/2023

Event Type  Injury  

Event Description

Reporter calling, stating she used replens earlier today and subsequently developed "terrible" abdominal cramps.Reporter states she searched online at "drugs.Com" and states that other individuals have reported this same problem after using the product.Reporter states "this is scary, it shouldn't happen." reporter states she called her gynecologist regarding her symptoms but has not yet received a call back from their office.Reporter provides product information including (b)(4) and also states that she has thrown the product in her trash can.

• Brand Name: REPLENS
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 17623583
• MDR Text Key: 322105241
• Report Number: MW5144938
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: KK30930
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female