MAUDE Adverse Event Report: JOHNSON & JOHNSON/ETHICON, INC. GYNECARE TVT EXACT CONTINENCE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Use of Device Problem (1670)

Patient Problems Erosion (1750); Pain (1994)

Event Date 04/19/2021

Event Type  Injury  

Event Description

I was told via telehealth online call to referred urogynocologist due to frequent urination and dr.Advised must have surgery no other options advised or discussed and placed a johnson and johnson ethicon gynecare bladder sling.I ended up from the day of surgery in pain and suffering for 2 years, i finally found a physician willing to remove the sling and still suffer.I ended up with erosion through my vaginal wall and nonstop pelvic pain and still suffer.Yes you may contact me.

• Brand Name: GYNECARE TVT EXACT CONTINENCE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): JOHNSON & JOHNSON/ETHICON, INC.
• MDR Report Key: 17201342
• MDR Text Key: 318024108
• Report Number: MW5118804
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/20/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White