BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOKOMATPRO

    MDR report key: 16791691 · Received April 21, 2023

    Report

    Report Number
    3003781275-2023-00001
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    June 1, 2018
    Report Date
    April 21, 2023
    Manufacturer
    HOCOMA AG
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRAINING WAS PERFORMED DESPITE CONTRAINDICATION (OSTEOPENIA). THE ADVERSE EVENT HAPPENED 5 YEARS AGO.

    Description of Event or Problem · 0

    DURING THE THIRD TRAINING, (WITH BODY WEIGHT SUPPORT OF 70%), AT 15 MIN OF TRAINING, THE PATIENT REFERRED PAIN TO THE LEFT FOOT WITH IMPOSSIBILITY TO CONTINUE GAIT. THE TREATMENT WAS STOPPED AND THE PATIENT WAS TAKEN TO HER ROOM. AFTER THE INCIDENT, THE PATIENT UNDERWENT X-RAY SHOWING OSTEOPENIA AND A COMPOSED FRACTURE (TRANSLATED FROM ITALIAN "COMPOSTA", THAT MEANS "NON-DISPLACED") OF CALCANEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791283 LOKOMATPRO ISOKINETIC TESTING AND EVALUATION SYSTEM IKK HOCOMA AG LOKOMATPRO L6.1 KOMBI, 220V

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other