MAUDE Adverse Event Report: COLOPLAST TSLING

Model Number T SLING

Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2014

Event Type  No Answer Provided  

Event Description

During transvaginal tape obturator procedure, sling was placed and left sheath would not release correctly.Sheath stretched and broke.Doctor removed it through suburethral incision.

• Brand Name: TSLING
• Type of Device: TSLING
• Manufacturer (Section D): COLOPLAST; minneapolis MN 55411
• MDR Report Key: 3607599
• MDR Text Key: 4159942
• Report Number: MW5034168
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: T SLING
• Device Catalogue Number: 519400
• Device Lot Number: 0850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR