BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND 5000

    MDR report key: 500812 · Received December 11, 2003

    Report

    Report Number
    2183634-2003-00001
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 14, 2003
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON PHOTOGRAPHS RECEIVED AND NOT PHYSICAL ANALYSIS CO HAS CONCLUDED THAT THE MATERIAL ON BOTH FRONT SIDE RAILS APPEARS TO HAVE TORN AWAY AT THE FRONT OF THE BASE. THIS MAY HAVE CAUSED THE USER TO FALL AND BREAK THEIR LEFT FEMUR. PHYSICAL ANALYSIS OF THE DEVICE MUST BE PERFORMED TO CONFIRM CO'S INITIAL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND 5000 STANDING ASSIST DEVICE IKX ALTIMATE MEDICAL, INC. EASYSTAND 5000 042499

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R