MAUDE Adverse Event Report: ETHICON, INC. TVT EXACT SLING; INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE

Lot Number 3935297

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

Tvt exact sling insertion device malfunction.Sling insertion device broke the white part of the sling.Fda safety report id # (b)(4).

• Brand Name: TVT EXACT SLING
• Type of Device: INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE
• Manufacturer (Section D): ETHICON, INC. ; somerville NJ 08876
• MDR Report Key: 11207437
• MDR Text Key: 228442197
• Report Number: MW5098912
• Device Sequence Number: 1
• Product Code: PWJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2021

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: Health Professional
• Device Lot Number: 3935297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR