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

Model Number 5195512400

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This event was previously submitted via asr on 24jun2019 (exemption number e2014015).This report is intended to be a follow-up to the previously submitted asr; any additional information received regarding this event will be submitted under this manufacturer report number.

Event Description

Additional information received further reported that in (b)(6) 2017, the patient underwent a revision of the eroded sling at the suture line, after a fall.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11841941
• MDR Text Key: 251207850
• Report Number: 2125050-2021-00549
• 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
• Type of Report: Initial
• Report Date: 05/18/2021

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: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 5190714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention