BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3013826 · Received March 20, 2013

    Report

    Report Number
    1531186-2013-01170
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE WHEELS ARE WARPED WHICH COMPROMISES THE STABILITY OF THE ROLLATOR AND COULD CAUSE THE USER TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115483 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other