BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142601 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00285
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    KENSTONE METAL
    Product Code
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY IS ALLEGED. ALLEGED MALFUNCTION. THE CONSUMER ALLEGES A DEFECTIVE FORK ON THE DEVICE, CAUSING THE WHEEL TO FALL OFF RESULTING IN THE CONSUMER FALLING. THE CONSUMER'S WEIGHT AND HEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL HISTORY AND STABILITY FOR USING THE DEVICE ARE UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. ANY ADDITIONAL LOADING TO THE DEVICE IS UNKNOWN. THE ENVIRONMENTAL CONDITIONS FOR THE FLOORING, STREET, OR TERRAIN ARE UNKNOWN.

    Description of Event or Problem · 1

    THE FORK WAS ALLEGEDLY DEFECTIVE, CAUSING THE WHEEL TO FALL OFF AND THE CONSUMER FELL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE N/A KENSTONE METAL 65960 KS100920

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR