BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4009505 · Received August 14, 2014

    Report

    Report Number
    1531186-2014-03206
    Date Received
    August 14, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MAXTHAI - MX - E. CHINA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER THE END USER, THEY FOUND A BLACK PIECE ON THE FLOOR WITH BBS INSIDE OF IT AND REALIZED THAT THE WHEEL IS BENT AND THE BRAKE WIRES ARE ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485238 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ MAXTHAI - MX - E. CHINA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other