MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SLING (COLOPLAST); FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Lot Number	AK060031_5195102400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient presented with pure stress incontinence, clinically well documented and unresponsive to perineal exercises.A trans obturator urethropexy with aris was performed on (b)(6) 2010 without complication.At follow-up, continence had improved but incompletely.There was marked deterioration in continence after 6 years, associated with pelvic pain and pain in both hips.Local infiltrations were attempted with temporary improvement, but the patient continued to experience bothersome pain and dyspareunia.Finally, she underwent complete removal of the tape on (b)(6) 2020.Progression showed an overall decrease in pain, but bilateral obturator myofascial pain persisted, requiring perineal physiotherapy and osteopathic treatment.Continence status is undetermined.
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.B3: estimated date.
Additional Manufacturer Narrative
Correction d3 manufacturer name g2 report source.Coloplast routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no corrective action is required at this time.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 SLING (COLOPLAST)
• Common Device Name: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• 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: 20533742
• Report Number: 2125050-2024-01712
• Device Sequence Number: 8218804
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 05/31/2015
• Device Lot Number: AK060031_5195102400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2010
• 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: 49 YR
• Patient Sex: Unknown