BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 6859873 · Received September 12, 2017

    Report

    Report Number
    3007615665-2017-00005
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 12, 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

    PATIENT SENT AN EMAIL ON (B)(6) 2017 AFTER HIS FIRST TRIAL IN THE REWALK ON (B)(6) 2017 AT SHARP REHAB REPORTING SWELLING IN HIS KNEES. HE SPENT 1.5 HOURS IN THE DEVICE, PERFORMING BALANCE AND WALKED 300 FT. NO SYMPTOMS NOTED IMMEDIATELY AFTER WALKING. HE SAYS HE TYPICALLY HAS VERY "SKINNY" KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640704 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention