BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE HD

    MDR report key: 1449545 · Received March 19, 2009

    Report

    Report Number
    1056127-2008-00005
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    July 9, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF SUBJECT UNIT SHOWED PROLONGED EXPOSURE TO SUN AS WELL AS OTHER WEATHER ELEMENTS INCLUDING EXTREMELY WORN TIRES, A CRACK IN THE LEFT REAR RIM, RUSTED HARDWARE, AND DRY ROTTED HANDGRIPS. WHEEL WAS MOST LIKELY CRACKED BEFORE IT BROKE AND THE PT CONTINUED TO USE IT. NEGLECT OF MAINTENANCE CONTRIBUTED TO THE MALFUNCTION. REPORT INITIATED FOLLOWING FDA AUDIT.

    Description of Event or Problem · 1

    PT WAS WALKING WITH UNIT ON OR ABOUT (B)(6) 2008 WHEN RIGHT REAR WHEEL BROKE, CAUSING HIM TO FALL FORWARD. THE PT FELL ONTO THE RIGHT ARM OF THE WALKER, CAUSING IT TO BEND, BEFORE LANDING ON THE GROUND. ACCORDING TO THE DEALER, THE PT ONLY HAD THE WALKER FOR ABOUT ONE YEAR. THE PT HAS SOME BUMPS AND BRUISES BUT DID NOT SUSTAIN ANY SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE HD WALKER, MECHANICAL ITJ ESSENTIAL MEDICAL SUPPLY, INC. W1800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA