MAUDE Adverse Event Report: COLOPLAST A/S ARIS; SURGICAL MESH

Model Number 5195101000

Device Problem Material Deformation (2976)

Patient Problem Incontinence (1928)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the medwatch form - mw5089178, this year the patient began having urinary leakage and difficulty emptying their bladder.Patient was seen by urogynecological specialist who diagnosed shrinkage and twisting of the sling.The patient had surgery to remove he sling and burch urethropexy.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation.No product was received for evaluation.Without examination of the product, quality cannot confirm the complaint as reported.As examination of the components may not conclusively confirm or disprove the report of urinary leakage and difficulty emptying their bladder, quality accepts the physician's observations as to the reason for medical intervention.Without examination of the product, quality cannot confirm the complaint as reported.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformance's and capas revealed no trends for this lot.

• Brand Name: ARIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9157947
• MDR Text Key: 161567586
• Report Number: 2125050-2019-00845
• 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: 12/16/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 5195101000
• Device Catalogue Number: 519510
• Device Lot Number: AQ040023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other