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

Catalog Number	93-4450 / 51956
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Hematuria (2558); Dysuria (2684); Urinary Incontinence (4572); Pelvic Pain (4865); Abnormal scarring (4896)
Date of Event	08/11/2021
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: a supris was implanted in (b)(6) 2014.From 2021, the patient reportedly experienced low back pain, pelvic pain, stress urinary incontinence, infection requiring medication, foul smelling discharge, bacterial vaginosis, suburethral mesh on physical exam, leukorrhea, urinary urge incontinence, mesh erosion, hematuria, buring with urination, severe tenderness in the intravaginal left levator ani area.Transvaginal removal of supris vaginal mesh with cystoscopy was performed.Intraoperative findings included adhesions and scarring along the urethra.Mesh was noted in the midline.The pathology report indicated: chronically inflamed connective tissue with foreign body consistent with mesh.2.0 x 1.6 x 0.1 cm.The patient reportedly continued to experience incomplete bladder emptying requiring intermittent catheterization and left sided pelvic pain.

• 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: 22689238
• Report Number: 2125050-2025-01234
• Device Sequence Number: 18427703
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 93-4450 / 51956
• Device Lot Number: 4063336_5195622400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2014
• 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: 54 YR
• Patient Sex: Unknown