MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC KIT; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number	51956
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Hematuria (2558); Lethargy (2560); Dysuria (2684); Constipation (3274); Kidney Infection (4502); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
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 urethrovaginal fistula, mesh erosion and stress urinary incontinence.The device was explanted.
Additional Manufacturer Narrative
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 recurrent urinary tract infections, dyspareunia, pain and pelvic pain, vaginal discharge, incomplete emptying, frequent urination, constipation, dysuria, painful bladder spasm and cystitis with hematuria.
Additional Manufacturer Narrative
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 lethargy, lower abdominal pain, kidney/renal pain, signs of systemic infection, urinary tract infection, acute pyelonephritis, mesh extrusion, pain with intercourse and tampon insertion.

• Brand Name: SUPRIS RETROPUBIC KIT
• 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: 21357270
• Report Number: 2125050-2025-00204
• Device Sequence Number: 8482119
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 05708932490016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 51956
• Device Lot Number: 7569356_5195622400
• 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: 02/11/2025
• Supplement Report FDA Received Date: 03/24/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2020
• 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: 50 YR
• Patient Sex: Female