BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3200527 · Received July 1, 2013

    Report

    Report Number
    9616091-2013-01120
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, MDR 9616091-2013-01120 WAS INADVERTENTLY SUBMITTED UNDER THE INCORRECT MANUFACTURER REGISTRATION NUMBER. THE CORRECT MANUFACTURER REGISTRATION NUMBER IS 1531186.

    Description of Event or Problem · 1

    PROVIDER STATES WHEEL, ONE REAR, IS CRACKED, SHATTERED AT THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300064 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other