BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 7385462 · Received March 30, 2018

    Report

    Report Number
    3007615665-2018-00001
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 15, 2018
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    UDI-DI
    00861803000303
    PMA / PMN Number
    K160987
    Removal / Correction Number
    Z-0944-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON STANDING (THE COMPANY REPRESENTATIVE WHO WAS IN TOUCH WITH THE USER BELIEVES IT WAS THE SECOND SIT TO STAND DURING THE SESSION), THE LEFT HAND (LH) FRONT KNEE BRACKET (FKB) CRACKED AND THE DEVICE RETURNED TO SIT POSITION. THE USER WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH BROKEN LEG (RIGHT LEG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230271 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL 00861803000303

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention