BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK REHABILITATION

    MDR report key: 6146349 · Received December 5, 2016

    Report

    Report Number
    3007615665-2016-00002
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 5, 2016
    Manufacturer
    REWALK ROBOTICS LTD
    Product Code
    PHL
    PMA / PMN Number
    K131798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE USER WAS HAVING ACUTE ADEMA IN HER RIGHT KNEE THE LAST FEW WEEKS. SHE HAD AN X-RAY THAT SHOWED POSSIBLE RIGHT TIBIA INSUFFICIENCY FRACTURE BUT THEY ARE RECOMMENDING AN MRI TO CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794794 REWALK REHABILITATION POWERED EXOSKELETON PHL REWALK ROBOTICS LTD REHABILITATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention