MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC OBTAPE TRANSOBTURATOR SLING

Catalog Number 93-4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Injury (2348)

Event Type  Injury  

Event Description

Serious and permanent bodily injuries including erosion of the ob tape through the pt's internal bodily tissues, chronic infections, pain, etc.

• Brand Name: OBTAPE TRANSOBTURATOR SLING
• Type of Device: TRANSOBTURATOR
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: christy babb ; 3041 skyway circle north; irving, TX 75038 ; 9722526060
• MDR Report Key: 3889133
• MDR Text Key: 16180163
• Report Number: 1645337-2014-00092
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 06/11/2014

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: Health Professional
• Device Catalogue Number: 93-4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other