BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4100646 · Received September 19, 2014

    Report

    Report Number
    1531186-2014-04269
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    JAN MAO
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES ALL THE SCREWS SEEM TO BE STRIPPED. UNABLE TO TIGHTEN CAUSING THE WALKER TO BE WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582548 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ JAN MAO 6441-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other