MAUDE Adverse Event Report: CHURCH AND DWIGHT REPLENS; PERSONAL LUBRICANT

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Irritation (1941); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 07/01/2016

Event Type  No Answer Provided  

Event Description

Since my wife experiences painful sex, we used the personal lubricant named replens topically with the amount of about a nickel on my two fingers and then applied just inside her vagina.The next day i started to feel some irritation inside the shaft of my penis.The second day the irritation was much worse.Burning and irritation with urination, shooting sharp pains in the shaft of my penis.The pain in my intestines, lower back, near my heart and upper left arm, and in my temples and other parts of my body.The nurse convinced me to see a urologist which i did finally see on (b)(6).He took another urine sample and provided me with a scope hooked up to a computer screen.He saw no obstructions.Had rock like bowel movements.Pains in my left upper shoulder, alongside my left breast and in the breast, pain and pressure in the left side and right side of my neck and numerous other pains in my toes, legs, etc.Replens is ruining my life both physically and psychologically.It had caused both physical and mental torture.Replens has caused many sleepless nights because of the pain it has and is still inflicting on me.

• Brand Name: REPLENS
• Type of Device: PERSONAL LUBRICANT
• Manufacturer (Section D): CHURCH AND DWIGHT
• MDR Report Key: 7057505
• MDR Text Key: 92977735
• Report Number: MW5073556
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1