BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE ULTRA SYSTEM

    MDR report key: 20988544 · Received December 20, 2024

    Report

    Report Number
    2124215-2024-80955
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF NEEDLE BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE KINKS NOTICED WITH THE SLING WHICH MOST LIKELY SUGGESTS THAT THE NEEDLE WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168879 ADVANTAGE ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown