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); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Discomfort (2330); Hematuria (2558); Dysuria (2684); Foreign Body In Patient (2687); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Interstitial Cystitis (4862); Pelvic Pain (4865)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.The device remains implanted.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 had an aris implanted in (b)(6) 2018.Reportedly, the patient experienced pelvic pain, groin pain, abdominal pain, vaginal pain, dyspareunia, bladder issues, and urinary issues, among other symptoms.Patient is currently receiving ongoing medical treatment for her injuries and is scheduled for mesh removal in the near future.Her future prognosis is unknown.
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 in veeva to be associated.The device remains implanted.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 in veeva to be associated.The device remains implanted.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 it was additionally reported: reportedly the patient experienced pain, little vaginal bleeding, frequent urinary tract infections [unlikely related to coloplast product], urinary frequency, dysuria, acute cystitis without hematuria, urinalysis ¿ trace leukocyte esterase, wbc 5-15, trace bacteria, foreign material in vagina, hematuria, dysuria, trouble urinating, straining or bearing down to start urinary stream, feels like she has to push her abdomen or move in a different position to empty bladder, exposed vaginal mesh-anterior vagina, neurogenic bladder [unlikely related to coloplast product], urine cytology showed precipitated hemoglobin [likely related to calcium oxalate crystals in urine], mesh exposure-approximately 1 cm x 0.5 cm area of visible mesh exposure at 3 o¿clock position, approximately 1 cm proximal to vaginal introitus, urinary incontinence, nocturia, incomplete bladder emptying, vaginal bleeding, dyspareunia, low back, constipation, urge urinary incontinence, pelvic floor muscle spasm, frequent urinary tract infection, cystitis, mesh poking out of vaginal area into legs, bleeding from mesh, green/yellow vaginal discharge, approximately 2 cm of left arm of sling exposed and retracted away from underlying vaginal tissue, stress urinary incontinence, urge urinary incontinence, muscle spasm-pelvic and constipation.
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient with this device additionally experienced bladder/vaginal pain/discomfort x 2-3 years, pneumaturia.Cystourethroscopy ¿ normal, no evidence of mesh intrusion into bladder.Pelvic exam ¿ mesh erosion through vaginal epithelium at 3 o¿clock position.
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 in veeva to be associated.The device remains implanted.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: 24188365
• Report Number: 2125050-2026-00134
• Device Sequence Number: 18136685
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 5708932442961
• 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
• 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,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 93-4400
• Device Lot Number: 6048610_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; Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/08/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2017
• 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: 43 YR
• Patient Sex: Unknown