MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC COLOPLAST SLING; STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR

Model Number 93-4450

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

The sling was inserted partially into the patient per surgeon.Surgeon placed a hemostat on the sling at the midway point of the sling.After placing the hemostat on, the sling tore.Surgeon removed the sling completely, and another device was open and inserted without any issues.Fda safety report id# (b)(4).

• Brand Name: COLOPLAST SLING
• Type of Device: STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 12878218
• MDR Text Key: 281346974
• Report Number: MW5105600
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 93-4450
• Device Catalogue Number: 93-4450
• Device Lot Number: 8021738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1