BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 8145104 · Received December 9, 2018

    Report

    Report Number
    3007615665-2018-00015
    Event Type
    Injury
    Date Received
    December 9, 2018
    Date of Event
    September 12, 2018
    Report Date
    December 9, 2018
    Manufacturer
    REWALK ROBOTICS LTD
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Removal / Correction Number
    Z-0944-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE USER BROKE HIS TIBIA, THERE IS NO ADDITIONAL DATA REPORTED TILL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984782 REWALK PERSONAL POWERED EXSOSKELETON, PRODUCT CODE: PHL PHL REWALK ROBOTICS LTD PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention