BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOKOMAT-SYSTEM

    MDR report key: 553523 · Received November 5, 2004

    Report

    Report Number
    3003781275-2004-00001
    Event Type
    Injury
    Date Received
    November 5, 2004
    Date of Event
    October 11, 2004
    Report Date
    October 29, 2004
    Manufacturer
    HOCOMA AG
    Product Code
    ISD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TRAINED AND CERTIFICATE THERAPIST WAS TRAINING A PT WITH A SPINAL CORD INJURY ON THE LOKOMAT. IT WAS A RECURRENCE TRAINING OF THE PT. AFTER A FEW MINUTES OF TRAINING THE FOOT OF THE PT GOT GAUGHT ON THE TREADMILL DURING THE BEGINNING OF THE SWINGPHASE. THE TENSION OF THE LOWER LEG CAUSED BY THE TREADMILL MADE THE TIBIA OF THE PT TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOKOMAT-SYSTEM POWERED EXERCISE EQUIPMENT ISD HOCOMA AG 4.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization