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	Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Fungal Infection (2419); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient had an aris implanted in (b)(6) 2021.Reportedly the patient experienced vaginal discharge "[did report having yeast infection after taking antibiotic after surgery]", abnormal urinary analysis (moderate leukocytes), mesh exposure right side of urethra, nocturia, dyspareunia, increased urinary frequency, incomplete emptying, pelvic pain, urinary urgency and change in urinary stream.Claimant felt something pop in her right side and reported having sensations of foreign body in her vagina that was also felt by her husband.Patient reportedly also experienced exposure of sling bilaterally and loss of "[urinary control.The patient underwent excision of eroded bladder sling via general anesthesia in (b)(6) 2025.Pathology showed benign squamous-lined fibroconnective tissue with chronic inflammation.Post excision, patient reportedly continued to experience urinary loss of control, difficulty urinating, incomplete emptying, pelvic pain, change in urinary stream and abnormal urinary analysis.
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.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.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: 50099164
• Report Number: 2125050-2026-01363
• Device Sequence Number: 9912991
• Product Code: OTN
• 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: 2021
• 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
• Report Date (Section B): 07/31/2026

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: 04/30/2024
• Device Catalogue Number: 93-4400
• Device Lot Number: 8022362_5195512400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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 Sex: Unknown