BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOKOMATPRO

    MDR report key: 14462245 · Received May 20, 2022

    Report

    Report Number
    3003781275-2022-00002
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    November 8, 2021
    Report Date
    May 20, 2022
    Manufacturer
    HOCOMA AG
    Product Code
    IKK
    UDI-DI
    07640174660254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SKIN LESIONS (INCLUDING PRESSURE SORES) IN AREAS OF CONTACT WITH HARNESS SUPPORT, ROBOTIC ORTHOSIS (BUTTOCKS AND ALONG LOWER EXTREMITIES) OR LOWER EXTREMITY LOADING (FEET). THERE ARE POPULATIONS WITH SENSITIVE SKIN AND COMORBIDITIES THAT IMPACT THE SKIN. THE CLINICIAN IN CHARGE HAS THE SOLE MEDICAL RESPONSIBILITY FOR THE REHABILITATION TREATMENT AND FOR DECIDING WHETHER A PATIENT IS FIT FOR A SPECIFIC TREATMENT. IN PARTICULAR, THE CLINICIAN MUST WEIGH IN EACH INDIVIDUAL CASE THE POSSIBLE RISKS AND SIDE EFFECTS AGAINST THE EXPECTED BENEFITS. IN ADDITION, THE PATIENT'S INDIVIDUAL SITUATION PLAYS JUST AS IMPORTANT A ROLE AS THE BASIC RISK ASSESSMENT FOR SPECIFIC PATIENT GROUPS. THE TREATING CLINICIAN IS RESPONSIBLE FOR ADAPTING THE TRAINING SESSIONS AND THE COURSE OF THERAPY TO THE PATIENT'S ABILITIES.

    Description of Event or Problem · 0

    INITIALLY LEFT GLUTEAL FOLD BRUISING AS A RESULT OF LOKOMAT USE. DEVELOPED INTO STAGEABLE IV WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618211 LOKOMATPRO SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK HOCOMA AG 07640174660254

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other