BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3981460 · Received August 5, 2014

    Report

    Report Number
    1531186-2014-03007
    Date Received
    August 5, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE RIGHT REAR WHEEL BEARING IS BROKEN AND WHEEL WILL NOT SPIN. CUSTOMER STATES THE END USER HAS HAD IT ABOUT 5 MONTHS. NO REPORTED INJURIES. WHEEL JUST DOESN¿T ROTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456982 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other