BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 8155073 · Received December 12, 2018

    Report

    Report Number
    3007615665-2018-00017
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 12, 2018
    Manufacturer
    REWALK ROBOTICS LTD
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE USER FALL WAS LOSS OF BALANCE; HOWEVER, IT IS NOT CLEAR HOW THE USER LOST HER BALANCE. WITH THE AVAILABLE DATA IT CAN BE CONCLUDED THAT: THE SYSTEM WAS INSPECTED AND NO MALFUNCTION WAS FOUND. THE USER TRIED TO WALK ALONE - WHICH IS AGAINST OUR RECOMMENDATIONS THAT EVERY REWALK USER, NO MATTER HOW SKILLED, SHOULD HAVE A TRAINED REWALK COMPANION ASSIST HIM DURING USE. THE CAUSE FOR THE FALL WAS THE USER'S MOMENTARY LOSS OF BALANCE, PROBABLY WHILE TURNING AROUND TO CLIMB THE STAIRS. A FITTING ADJUSTMENT WAS DONE ABOUT 20 MIN BEFORE THE FALL AND WAS APPROVED BY THE USER - ACCORDING TO THE WW TRAINING MANAGER THIS FITTING COULD MAKE AN IMPACT ON BALANCE BUT IS UNLIKELY TO CAUSE THE FALL.

    Description of Event or Problem · 1

    DURING WALKING WITH THE REWALK DEVICE THE PATIENT LOST BALANCE AND FELL BACKWARDS; THE PATIENT (SHE) HIT THE GROUND WITH THE BACK OF HER HEAD. THE HEALTH SITUATION WAS UNCLEAR AND SHE WAS TAKEN TO THE HOSPITAL. THE IMMEDIATE OUTCOME AFTER THE FALL WAS: BRACHIAL PLEXUS STRETCH LEFT AND RIGHT; BRACHIAL PLEXUS COMPRESSION LEFT DUE TO A HEMATOMA; HEADACHE' THE USER WAS HOSPITALIZED AND RELEASED AFTER FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995284 REWALK PERSONAL POWERED EXSOSKELETON, PRODUCT CODE: PHL PHL REWALK ROBOTICS LTD PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization