BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE FOLDING WALKER

    MDR report key: 3143195 · Received May 30, 2013

    Report

    Report Number
    1056127-2013-00009
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    COM-BRIDGE INTERNATIONAL CO., LTD
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER WAS CALLED TO HER FATHER'S BEDROOM WHERE SHE SAW THE WALKER WITH A BROKEN LEG PROPPED UP AGAINST THE WALL. THE PATIENT TOLD DAUGHTER THAT HE HAD FALLEN AND HIT HIS HEAD, BUT WHEN SHE HAD ENTERED THE ROOM HE WAS STANDING UPRIGHT AND DIDN'T SHOW ANY SIGNS OF BEING HURT OR BRUISED. NO MEDICAL ATTENTION WAS SOUGHT. PATIENT HAS DEMENTIA AND IS UNABLE TO PROVIDE FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240113 ENDURANCE FOLDING WALKER WALKER, MECHANICAL ITJ COM-BRIDGE INTERNATIONAL CO., LTD WK501-5W

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR