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

Catalog Number	93-4400
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Fever (1858); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Impaired Healing (2378); Hematuria (2558); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3, d6a/b: dates not known.Best estimate unable to be provided as year not known.As no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed at this time.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 experienced erosion, bleeding, infections, bladder leakage, vaginal pain, vaginal scarring, dyspareunia, recurrence [incontinence], urinary urgency, incontinence, physical deformity, and difficulty with daily activities.The device was surgically removed.
Additional Manufacturer Narrative
B3, d6a/b: dates not known.Best estimate unable to be provided as year not known.As no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed at this time.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 experienced exposed vaginal mesh, urinary tract infection, fever, infection consisting of escherichia coli and wound breakdown.
Additional Manufacturer Narrative
Correction: h6 (part 2).Medical device problem code: removed a24 as no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed at this time.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 vaginal yeast infection, bacterial vaginosis, urinary tract infection with hematuria, bladder spasms, dysuria, urinary frequency, states sling has been actively eroding through/coming out of vagina.Vaginal atrophy.Cystoscopy ¿ normal, trapping of urine due to very narrow introitus.Recurrent stress urinary incontinence, fever, vaginal closure has fallen apart, now with (1 x 2 cm) area of fascial sling exposure, vaginal wall is eroded with wound breakdown, bad odor at times, suprapubic tenderness.Vaginal closure has fallen apart with (2 cm) area of fascial sling exposure with palpable sutures.

• 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: 21858187
• Report Number: 2125050-2025-00629
• Device Sequence Number: 20007537
• 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: 2015
• Device Explanted Year: 2024
• 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): 05/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 93-4400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/29/2025; 05/13/2026
• 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: 55 YR
• Patient Sex: Unknown