BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT ULTRA SYSTEM

    MDR report key: 22080436 · Received May 23, 2025

    Report

    Report Number
    2124215-2025-33630
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007669
    PMA / PMN Number
    K211223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE ADVANTAGE ULTRA DEVICE RECEIVED FDA CLEARANCE THROUGH TWO SEPARATE 510(K) APPROVALS: K211223 AND K231549. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF MESH DETACHMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE SLING PROCEDURE USING THE ADVANTAGE FIT ULTRA SYSTEM DEVICE, THE MESH DETACHED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367725 ADVANTAGE FIT ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068502160 0035849893 00191506007669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown