MAUDE Adverse Event Report: JOHNSON AND JOHNSON TVT

Device Problem Difficult to Insert (1316)

Patient Problem Perforation (2001)

Event Date 09/22/2015

Event Type  Injury  

Event Description

Small intestinal perforation from tension free vaginal tape insertion.

• Brand Name: TVT
• Type of Device: TVT
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 5161742
• MDR Text Key: 28822684
• Report Number: MW5057199
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Weight: 82