BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 6227185 · Received January 5, 2017

    Report

    Report Number
    3007615665-2017-00003
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 28, 2016
    Report Date
    January 5, 2017
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    DURING TRAINING SESSION A COUPLE OF LOUD CRACKS WERE HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7501 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention