BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK

    MDR report key: 3113837 · Received May 15, 2013

    Report

    Report Number
    3007615665-2013-00001
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 11, 2013
    Manufacturer
    ARGO MEDICAL TECHNOLOGIES
    Product Code
    BXB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS CURRENTLY UNDERWAY WITH NO CONCLUSIONS REACHED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS PERFORMING A SIT-TO-STAND WHEN THE DEVICE MALFUNCTIONED. DURING THE STAND THE KNEES EXTENDED, BUT THE HIPS STAYED RELATIVELY FLEXED. IT SEEMED THAT THE LEFT HIP STAYED AT 90 DEGREES WHILE THE RIGHT WAS TRYING TO EXTEND. THE RESULT WAS A BIT OF A TWISTING FORCE COMBINED WITH THE HIP FLEXION. THE DEVICE STAYED POWERED ON DURING THE ENTIRE SIT-TO-STAND AND WAS TURNED OFF BY THE THERAPIST TO HELP GET THE PATIENT OUT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215458 REWALK 890.5380 BXB ARGO MEDICAL TECHNOLOGIES REHABILITATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization