BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 6158926 · Received December 9, 2016

    Report

    Report Number
    3007615665-2016-00004
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 9, 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
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, IT WAS FOUND THAT THE PATIENT HAD A DISTINCT C SHAPED LINE ON THE BOTTOM OF HIS HEEL WHICH APPEARED TO BE BRUISING. THE DEVICE'S FOOT PLATE EXAMINED IN RELATION TO THE PATIENT'S SHOE AND DETERMINED THEY WERE USING A SMALLER FOOTPLATE THAN WAS APPROPRIATE. THE PATIENT WAS MOST LIKELY STANDING ON THE HEEL CUP OF THE FOOT PLATE THROUGHOUT HIS LAST TRAINING SESSION, WHICH COULD HAVE CAUSED THE LESION. THE FOOTPLATES WERE SWITCHED TO LARGER ONES AND THE PATIENT DONNED THE DEVICE. UPON STANDING, THE PATIENT REPORTED NO DEEP PRESSURE IN THE R FOOT WHICH HE WAS EXPERIENCING IN THE PRIOR SESSION.

    Description of Event or Problem · 1

    THE THERAPISTS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING R ANKLE EDEMA AND REDNESS. UPON THEIR INSPECTION, IT WAS FOUND THAT THE PATIENT HAD A DISTINCT C SHAPED LINE ON THE BOTTOM OF HIS HEEL WHICH APPEARED TO BE BRUISING. SEVERAL DAYS LATER, IT WAS COMMUNICATED VIA A PHONE CALL THAT THE PATIENT'S R ANKLE SWELLING HAD NOT SUBSIDED AND HAD A FOLLOW-UP APPT SCHEDULED WITH AN MD. AFTER EXAMINATION WITH THE MD, WHERE X-RAYS WERE TAKEN, IT WAS DETERMINED THAT THE PATIENT HAD SUSTAINED A SUPERIOR CALCANEOUS FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807690 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention