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); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Dysuria (2684); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced excision of device.Cystoscopy intraoperative findings: 1.3 x 3 cm exposed suburethral mesh.Pathology report: the specimen consists of a portion of clear medical mesh with adherent vaginal tissue and hemorrhagic tissue measuring 3.5 cm in length and 1.3 cm in diameter.The adherent vaginal tissue and hemorrhagic tissue is removed and measures 2.0 x 1.0 x 0.1 cm in aggregate.
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.
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.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced vaginal odor, recurrent urinary tract infection, husband being able to feel vagina mesh, burning with urination.Occasional urgency urinary incontinence, vaginal bleeding, soreness with exertion and urination, vaginal mesh exposure 3x3 cm underneath urethra, vaginal discharge, repeat vaginal infections and ultimate suburethral mesh revision and cystoscopy.Pathology report noted clear medical mesh with adherent vaginal tissue and hemorrhagic tissue 3.5 x 1.3 cm with final diagnoses of squamous epithelium and granulation tissue including numerous neutrophils and blood clot.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device additionally experienced pelvic pain, dyspareunia and recurrent vaginal infections.It was reported the patient has suffered and continues to suffer with urinary incontinence, physical deformity, and the loss of the ability to perform sexually.As reported to coloplast, though not verified, the patient with this device experienced excision of device.Cystoscopy intraoperative findings: 1.3 x 3 cm exposed suburethral mesh.Pathology report: the specimen consists of a portion of clear medical mesh with adherent vaginal tissue and hemorrhagic tissue measuring 3.5 cm in length and 1.3 cm in diameter.The adherent vaginal tissue and hemorrhagic tissue is removed and measures 2.0 x 1.0 x 0.1 cm in aggregate.
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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21313732
• Report Number: 2125050-2025-00163
• Device Sequence Number: 8876890
• 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: 2021
• Device Explanted Year: 2023
• 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): 09/16/2025

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 93-4400
• Device Lot Number: 7664740_5195512400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 05/07/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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 Age: 52 YR
• Patient Sex: Female