BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUE MALE SLING SYSTEM

    MDR report key: 22843623 · Received August 19, 2025

    Report

    Report Number
    2125050-2025-01340
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 20, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTM
    UDI-DI
    05708932499149
    PMA / PMN Number
    K101297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251325 VIRTUE MALE SLING SYSTEM MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER OTM COLOPLAST A/S 9728969_5002041400 05708932499149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown