BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATORS-615

    MDR report key: 19348130 · Received May 18, 2024

    Report

    Report Number
    3014644996-2024-00007
    Event Type
    Malfunction
    Date Received
    May 18, 2024
    Report Date
    May 18, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER HAS A STEELING ROLLING WALKER AND THE RIGHT BRAKE HANDLE HAS COME OFF, THE BRAKE LEVER IS COMPLETELY GONE AS HIS AUNT CAME HOME WITH IT MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642663 ROLLATORS-615 WALKER ITJ COM-DA HEALTHCARE CO.,LTD 1-FGA22100 0000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown