BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3963840 · Received July 29, 2014

    Report

    Report Number
    1531186-2014-02833
    Date Received
    July 29, 2014
    Report Date
    June 24, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, WHEN OPEN WALKER AND LOCK THERE IS TOO MUCH PLAY CAUSING UNIT TO BE WOBBLY, DEALER ADVISED END-USER WAS SITTING ON THE BED AND THEN GOT UP AND STARTING WALKING, END-USER FELL WHILE WALKING OUT OF THE BEDROOM THROUGH THE DOOR, END-USER ADVISED HIT HER HEAD ON RIGHT TOP SIDE WITH A LITTLE BIT OF BLOOD COMING OUT ALSO BRUISED HER RIGHT SHOULDER, DEALER ADVISED END-USER DID NOT SEEK MEDICAL ATTENTION, DEALER COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441531 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 6291-5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other