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

Catalog Number	51956 / 93-4450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Foreign Body Reaction (1868); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Abdominal Cramps (2543); Neuralgia (4413); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	01/10/2022
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 in veeva to be associated.
Event or Problem Description
As reported to coloplast, though not verified: following a supris being implanted in the patient, the patient had recurrent stress urinary incontinence, mesh erosion requiring trimming under local anesthesia and a history or urethral fistula repair.
Event or Problem Description
As additionally reported to coloplast, though not verified, the patient with this device also experienced urinary tract infection, bulkamid periurethral injections, excision of urethrovaginal fistula, urethroplasty, bilateral ureteral catheterization and cystoscopy under laryngeal mask anesthesia.Findings included residual mid urethral sling mesh found deeper in the sulcus which was noted to have no relation to the urethrovaginal fistula tract.Pathology report noted squamous mucosa with chronic inflammation and foreign body giant cells surrounding polarizable material.The patient was scheduled for revision surgery.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.Correction: h6 health effect clinical code e2314 fistula was removed.
Event or Problem Description
As additionally reported to coloplast, though not verified: following implant of the supris, the patient subsequently suffered complications associated with the pelvic mesh product, including, exposure of the mesh, protrusion of the mesh, mesh contraction, scarring, bleeding, extreme pelvic and abdominal pain and cramping, irregular discharge, vaginal pain, dyspareunia, urinary urgency problems, permanent disfigurement, infection, trouble voiding, nerve damage and pain and difficulty with daily activities, which required surgical revision and/or removal procedures.The patient has reportedly also had to use pain control and other medications and operations to remove portions of the female genitalia.
Event or Problem Description
As additionally reported to coloplast, though not verified: the patient underwent further urethrolysis in 2024.Cystourethroscopy intraoperative findings included significant peri-urethral scar formation.No vaginal mesh found and no urethrovaginal fistula noted.Patient continued to have some air passage per urethra, urge incontinence, frequency and overactive bladder.

• 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 (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20128480
• Report Number: 2125050-2024-01356
• Device Sequence Number: 17996436
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 05708932490016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 09/30/2025
• Device Catalogue Number: 51956 / 93-4450
• Device Lot Number: 8021738_5195622400
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/05/2024; 01/07/2025; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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; Disability
• Patient Age: 65 YR
• Patient Sex: Female