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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Impaired Healing (2378)
Date of Event	03/01/2024
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 in veeva to be associated.B3: estimated date.
Event or Problem Description
As reported to coloplast, though not verified, the patient had a supris implanted in (b)(6) 2017.Reportedly in (b)(6) 2018 the mid urethral sling incision had not healed.A 0.5cm portion of the incision was still open with exposed sling.In (b)(6) 2018 advancement of the vaginal flap to cover exposed supris mesh was performed under general anesthesia.Intraoperative findings: 1 cm sling exposed through midline of the anterior vaginal wall.

• 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: 20568780
• Report Number: 2125050-2024-01762
• Device Sequence Number: 7872575
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 5708932490016
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 08/31/2021
• Device Catalogue Number: 51956
• Device Lot Number: 5799806_5195622400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2017
• 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: 73 YR
• Patient Sex: Female