BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4122661 · Received September 26, 2014

    Report

    Report Number
    1531186-2014-04488
    Date Received
    September 26, 2014
    Report Date
    September 10, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE BRAKES ON HER 66550 WALKER MUST NOT HAVE BEEN LOCKED WHILE SHE WAS SITTING, CAUSING THE CASTER WHEEL TO BEND AND HER TO FALL FROM THE WALKER. USER SUSTAINED AN INSTANT HEADACHE AND BRUISES. SHE STATES THAT THE CASTER HAS BEEN BENT BACK INTO PLACE, BUT IS WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601420 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other