MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON, INC. ABBREVO TVT; GUNECAVE MESH SURGICAL

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 12/09/2016

Event Type  Injury  

Event Description

My abbrevo mesh implanted (b)(6) 2016 became extremely painful.It was tight hard and sharp.My muscles went into spasms and i was all swollen.I couldn't sit or stand without extreme pain.I had groin pain and nerve impingement and had no strength in my right leg.I went to doctor he burned two spots in my vagina with silver nitrate because of erosion.I had to find a removal doctor because my doctor would only do a partial.I had the sling removed on (b)(6) 2017.The sling had felt tight since it was implanted and became unbearable.

• Brand Name: ABBREVO TVT
• Type of Device: GUNECAVE MESH SURGICAL
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON, INC.
• MDR Report Key: 6885744
• MDR Text Key: 87231722
• Report Number: MW5072274
• 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: 09/21/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 88