MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC COLOPLAST ARIS IMPLANT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Catalog Number 9340010

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Twisted/Bent (2981)

Patient Problem Incontinence (1928)

Event Date 06/27/2019

Event Type  Injury  

Event Description

Pt had surgical placement of urethral sling (b)(6) 2016.This year she began having urinary leakage and difficulty emptying her bladder.She was seen by urogynecologic specialist who diagnosed shrinkage and twisting of the sling.Pt required surgery on (b)(6) 2019 for removal of urethral sling and burch urethropexy.Fda safety report id# (b)(4).

• Brand Name: COLOPLAST ARIS IMPLANT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 8912219
• MDR Text Key: 155118759
• Report Number: MW5089178
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 9340010
• Device Lot Number: AQ040023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 61