MAUDE Adverse Event Report: COLOPLAST T-SLING UNIVERSAL; MESH, SURGICAL, GYNECOLOGIC

Model Number 519400

Device Problem Malposition of Device (2616)

Patient Problem Discomfort (2330)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Patient has a past medical history of a synthetic mid urethral sling for stress incontinence.She postoperatively could feel the mesh during intercourse and had discomfort with this.There was a thin area over the mesh and the patient was trialed on premarin cream; however, this was unsuccessful.Given this, she presented today for the operating room to have removal of exposed mesh.Patient had dissection and removal of exposed vaginal mesh.

• Brand Name: T-SLING UNIVERSAL
• Type of Device: MESH, SURGICAL, GYNECOLOGIC
• Manufacturer (Section D): COLOPLAST; 1601 west river road; minneapolis, MN 55411
• MDR Report Key: 5415897
• MDR Text Key: 37628820
• Report Number: 5415897
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

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
• Device Model Number: 519400
• Device Lot Number: 0920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1