BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 14346328 · Received May 10, 2022

    Report

    Report Number
    3003898228-2022-00004
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 12, 2022
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWT
    UDI-DI
    03661489611032
    PMA / PMN Number
    K093599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THERE IS A WEAR IN TIP OF THE PRODUCT.

    Description of Event or Problem · 0

    THERE ARE A WEAR IN TIP OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233264 ARROW ARROW CHISEL KWT FH INDUSTRIE 261103 RC7287-14 03661489611032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown