MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated plaintiff suffered severe pain with daily activities and intercourse, chronic urinary tract infections as well as urinary frequency and urgency.Plaintiff underwent a surgical procedure during which her physicians excised and removed a portion of the mesh.Plaintiff has suffered, and continues to suffer, multiple, severe and painful personal injuries, including, but not limited to, vaginal prolapse, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.

Manufacturer Narrative

This follow-up mdr is created to document a review of the complaint history database, nonconformance's and capas revealing no trends for this lot.

• Brand Name: ARIS TRANS-OBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9412925
• MDR Text Key: 169140587
• Report Number: 2125050-2019-01061
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 2703965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other