BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142614 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00275
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY IS ALLEGED. ALLEGED MALFUNCTION. THE CONSUMER ALLEGES THREADS ON THE CASTER STEM WERE CAUSING THE WHEEL TO COME OFF ULTIMATELY RESULTING IN A FALL. THE CONSUMER'S WEIGHT AND HEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL HISTORY FOR USING THE DEVICE IS UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. ANY ADDITIONAL LOADING TO THE DEVICE IS UNKNOWN. THE CONSUMER'S STABILITY IS UNKNOWN. THE ENVIRONMENTAL CONDITIONS FOR THE FLOORING, STREET OR TERRAIN ARE UNKNOWN. MDR FILED BASED ON THE MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS USING THE KNEE WALKER WHEN THE WHEEL ALLEGEDLY CAME OFF, CAUSING THE CONSUMER TO FALL TO THE GROUND. THE THREADS ON THE CASTER STEM WERE ALLEGEDLY STRIPPED. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITJ KENSTONE METAL 65960 NA

    Patients

    Seq Age Sex Outcome Treatment
    1