BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4093306 · Received September 16, 2014

    Report

    Report Number
    1531186-2014-04158
    Date Received
    September 16, 2014
    Report Date
    August 26, 2014
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DEALER THAT THE BACK BRACE WAS BROKE ON THE LEFT SIDE. NO PATIENT INJURY ALLEGED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570875 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other