MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE MALE SLING SYSTEM; MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number	50020
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code a2303 was added to capture the device being implanted post expiration date.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.According to the available information, it was identified that expired product was implanted into a patient on (b)(6) (expired on 8/5/2024).Based on the picture of the label provided and verification of expiration date for this lot in coloplast's production system, it can be confirmed the product was expired (expiration august 5,2024).This means the product was implanted 8 days beyond the labeled expiration date.The instructions for use (ifu) includes a warning to not use product beyond the indicated expiration date.The risk to the patient is not increased as coloplast's real time aging results for the virtue product supports that the product continues to meet requirements beyond the fda approved 3-year labeled shelf life and within the timeframe this product was used.
Event or Problem Description
According to the available information, the virtue was implanted 8 days post expiration date.

• Brand Name: VIRTUE MALE SLING SYSTEM
• Common Device Name: MALE 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: 20140249
• Report Number: 2125050-2024-01365
• Device Sequence Number: 7417059
• Product Code: OTM
• UDI-Device Identifier: 05708932499149
• UDI-Public: 05708932499149
• Combination Product (Y/N): N
• PMA/510(K) Number: K101297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2024
• Device Catalogue Number: 50020
• Device Lot Number: 9015433_5002041400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Unknown