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	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr for lot: 9728969, (pn: 5002041400, qty: (b)(4) was reviewed.There were no ncrs or capas tied to lot: 9728969.The lot of alexis wound retractors contained the expiration date of 2025-07-21 which did not align with the indicated virtue fg expiration date.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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
According to the available information, the virtue retail box and introducer tray label indicates an expiration date of 8/7/2025; however, the component (alexis retractor) inside of the retail box indicated an expiration date of 7/21/2025.Solely the virtue sling was utilized from this kit.The expired alexis retractor was not used on the patient.
Additional Manufacturer Narrative
Quality reviewed the images and verified an expiration date misalignment.Upon review of production paperwork, the same misalignment was identified in the retrained label copies.The virtue retail box and introducer tray label indicates an expiration date of 2025-08-07; however, the component (alexis retractor) inside of the retail box of the complaint unit indicated an expiration date of 2025-07-21.The production paperwork was reviewed.There was a total of (b)(4) units created of the virtue kits.The kits encompassed multiple lots of alexis wound retractors (2309290387, 2301060230, and 2402260450) the expiration date for 2402260450 is 2025-07-21, which is earlier than the higher-level virtue lot expiration date of 2025-08-07.The expiration dates for the other alexis lots 2309290387 and 2301060230 are 2026-05-08 and 2025-08-07, respectively, both of which are either the same or after the virtue 2025-08-07 expiration date given the information collected during this investigation and the one confirmed non-conforming unit in the field, (b)(4) was created to document and address the non-conformance reported in this complaint.Product in the field was assessed as part of the health hazard evaluation process.No product has been recalled as any remaining virtue product in the field for this lot is now expired as of 2025-08-07.
Event or Problem Description
According to the available information, the virtue retail box and introducer tray label indicates an expiration date of 8/7/2025; however, the component (alexis retractor) inside of the retail box indicated an expiration date of 7/21/2025.Solely the virtue sling was utilized from this kit.The expired alexis retractor was not used on the patient.

• 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: 22843623
• Report Number: 2125050-2025-01340
• Device Sequence Number: 15861833
• Product Code: OTM
• UDI-Device Identifier: 05708932499149
• UDI-Public: 05708932499149
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: Lay User/Patient
• Device Expiration Date: 08/07/2025
• Device Catalogue Number: 50020
• Device Lot Number: 9728969_5002041400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2023
• 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 Sex: Unknown