BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND 5000

    MDR report key: 622827 · Received July 25, 2005

    Report

    Report Number
    2183634-2005-00001
    Event Type
    Injury
    Date Received
    July 25, 2005
    Date of Event
    June 27, 2005
    Report Date
    June 28, 2005
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERAPIST CALLED AND STATED THEY WERE DOING A PIVOT TRANSFER ON A PT INTO AN EASYSTAND 5000. THE THERAPIST WENT ON TO STATE THAT THIS INDIVIDUAL HAS VERY HIGH TONE IN THEIR LEGS AND HALFWAY THROUGH THE TRANSFER EXTENSOR TONE KICKED IN IN THEIR LEGS AND THEIR LEGS PULLED BACK TOWARD THE QUICK ADJUST HANDLE USED TO ADJUST THE FOOTPLATES ON THE STANDING FRAME. THE FORCE CAUSED A PUNCTURE WOUND IN THEIR LEG APPROXIMATELY THREE INCHES DEEP WHICH REQUIRED A TRIP TO THE ER WHERE THE PT RECEIVED STITCHES FOR THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND 5000 STANDING ASSIST DEVICE IKX ALTIMATE MEDICAL, INC. EASYSTAND 5000 010400

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention