MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT ABBREVO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTOML

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

An abbrevo tvt sling had the tip come out the side through the plastic.The sling is now unusable.

• Brand Name: GYNECARE TVT ABBREVO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; route 22 west; somerville NJ 08876
• MDR Report Key: 3831887
• MDR Text Key: 4498699
• Report Number: 3831887
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3740842
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2014
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 76