MAUDE Adverse Event Report: COLOPLAST T-SLING UNIVERSAL SLING

Model Number 519400

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Vascular Dissection (3160)

Event Type  Other  

Event Description

A transobturator sling was placed in appropriate position.Plastic sleeve tore during the procedure, dislodging the sling.Vulva had to be dissected and sling had to be removed due to now improper placement.

• Brand Name: T-SLING UNIVERSAL SLING
• Type of Device: T-SLING UNIVERSAL SLING
• Manufacturer (Section D): COLOPLAST; 55411
• MDR Report Key: 4253563
• MDR Text Key: 5012193
• Report Number: MW5039075
• Device Sequence Number: 1
• Product Code: OTN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 519400
• Device Lot Number: 0927
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2014
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 83