MAUDE Adverse Event Report: ETHICON J&J TVT

Device Problem Material Erosion (1214)

Patient Problem Pain (1994)

Event Date 01/07/2011

Event Type  Injury  

Event Description

I was implanted with a transvaginal bladder mesh device for incontinence.The device has eroded through my vaginal walls, requiring surgical removal and what was left behind after that surgery is now hardening and contracting on my bladder.I have suffered horrendous pain in my pelvic area.I am hoping to have this mesh fully removed soon.

• Brand Name: TVT
• Type of Device: TVT
• Manufacturer (Section D): ETHICON J&J
• MDR Report Key: 6066659
• MDR Text Key: 58916212
• Report Number: MW5065687
• Device Sequence Number: 1
• Product Code: PAI
• 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: 10/27/2016

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 131