BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4001602 · Received August 12, 2014

    Report

    Report Number
    1525712-2014-04540
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    March 3, 2014
    Report Date
    July 9, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER STATED THAT WHILE SHE WAS WALKING DOWN THE STREET ON SIDEWALKS THAT WERE UNEVEN, THE BEARINGS IN FRONT WHEEL LOCKED UP, CAUSED FRONT WHEEL TO SPIN AND SHE FELL FORWARD ONTO THE GROUND. END USER WAS NOT INJURED, AND SHE COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480192 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other