BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 10050473 · Received May 13, 2020

    Report

    Report Number
    3007615665-2019-00003
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 8, 2020
    Manufacturer
    REWALK ROBOTICS LTD
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROCESS. THE DEVICE WILL BE INSPECTED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    AFTER PATIENT FINISHED HER 3RD TRAINING SESSION IN REWALK P6.0 (NEW USER), ON (B)(6) 2019 SHE NOTICED HER LEFT KNEES WAS SWOLLEN. ON (B)(6) 2019 REWALK ROBOTICS WAS UPDATED BY PATIENT THAT SHE WAS DIAGNOSED WITH A SMALL LATERAL TIBIAL PLATEAU FRACTURE IN HER LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516302 REWALK PERSONAL POWERED EXSOSKELETON, PRODUCT CODE: PHL PHL REWALK ROBOTICS LTD PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention