BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 7443771 · Received April 19, 2018

    Report

    Report Number
    3007615665-2018-00009
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    May 10, 2017
    Report Date
    April 19, 2018
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Removal / Correction Number
    Z-0944-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED HEREIN WAS DISCLOSED TO THE FDA ON 3 OCCASIONS IN A ROOT CAUSE ANALYSIS ((B)(4)) WHICH WAS PART OF; ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00003) DATED AUG 10, 2017; ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00004) DATED AUG 23, 2017; CLASS 2 DEVICE RECALL REWALK PERSONAL 6.0 (RECALL NUMBER Z-0944-2018, RECALL EVENT ID (B)(4)).

    Description of Event or Problem · 1

    THE USER REPORTED SWOLLEN LEFT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288587 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention