MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	519551 / 93-4400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572); Urolithiasis (4861); Interstitial Cystitis (4862); Pelvic Pain (4865)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced ongoing and recurrent urinary tract infections, dysuria, pain, bloating, pelvic pain, pyuria, urinary frequency and urgency, nausea, dyspareunia, recurrent incontinence, cystitis, sling erosion, bladder stone and removal of eroded segment of device.A 1cm bladder stone was found adhered to the segment of eroded sling.
Additional Manufacturer Narrative
As no valid lot number was provided, a review of the device history record, complaint history database, nonconformance's and capas could not be completed.The device was not returned for evaluation.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21605673
• Report Number: 2125050-2025-00412
• Device Sequence Number: 18445836
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 519551 / 93-4400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Unknown