MAUDE Adverse Event Report: Coloplast A/S Aris transobturator System; Suture/needle passer, single-use

Catalog Number	93-4400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Pain (1994); Urinary Retention (2119); Hematuria (2558); Dysuria (2684); Neuralgia (4413); Dyspareunia (4505); Pelvic Pain (4865)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced acute post-operative urinary retention with abdominal pressure and was passing blood clots.The patient was discharged home with a catheter.In 2025, the patient experienced nerve pain, pulling sensation in the left groin and palpable mesh to the left lateral side of the urethra with 1 cm exposed.Mesh removal recommended.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.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.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device additionally experienced, able to feel plastic inside vaginal wall.Physical exam noted (b)(6) strip of exposed sling mesh.Pelvic and perineal pain.Dyspareunia, oab, feeling of incomplete bladder emptying.Partial mesh removed recommended.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.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 (Section G): Minneapolis
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22286394
• Report Number: 2125050-2025-00998
• Device Sequence Number: 15658416
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 93-4400
• Device Lot Number: 8373488_5195512400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/20/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 06/26/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2021
• 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: 42 YR
• Patient Sex: Female