BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 6156331 · Received December 8, 2016

    Report

    Report Number
    3007615665-2016-00003
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    June 4, 2016
    Report Date
    December 8, 2016
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER PARTICIPATED ONCE IN A CLINIC DAY SESSION ON (B)(6) 2016. DURING SESSION, STOOD UP, WALKED A FEW STEPS HAD A GREAT SESSION. LATER THAT DAY FELT PAIN IN HER LEFT ANKLE. SHE WENT TO SEE THE DOCTOR 4 DAYS LATER (APPROXIMATELY (B)(6) 2016). NO IMAGING TAKEN, BUT IT WAS PRESCRIBED AND STRONGLY RECOMMENDED BY DOCTOR. PATIENT WAS DISCHARGED AGAINST MEDICAL ADVICE. SWELLING DIDN'T CHANGE, NO TREATMENT PROVIDED BY PATIENT CHOICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804452 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention