BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOKOMAT

    MDR report key: 9408675 · Received December 4, 2019

    Report

    Report Number
    3003781275-2019-00002
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    October 25, 2019
    Report Date
    February 28, 2020
    Manufacturer
    HOCOMA AG
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL REPORT OF 3003781-2019-00002. ROOT CAUSE ANALYSIS COMPLETED: THE SPECIFIC SETTING WAS NOT AS INTENDED ACCORDING TO THE INSTRUCTION FOR USE. NO DEVICE FAILURE COULD BE IDENTIFIED. DETECTED USER ERROR: - PADDING WAS NOT USED TO PROTECT SKIN AS INDICATED IN THE INSTRUCTION OF USE. - RISK FACTOR: "SKIN LESIONS (INCLUDING PRESSURE SORES) IN AREAS OF CONTACT WITH HARNESS SUPPORT, ROBOTIC ORTHOSIS (BUTTOCKS AND ALONG LOWER EXTREMITIES) OR LOWER EXTREMITY LOADING (FEET)" WAS NEGLECTED. AS A RE-TRAINING, THE CLINIC AGAIN RECEIVED A DETAILED DESCRIPTION ON HOW TO DO A PROPER SET-UP (HOCOMA KNOWLEDGE PLATFORM ENTRY "HOW CAN I PROTECT PATIENTS' SKIN WHEN THEY TRAIN ON THE LOKOMAT?").

    Additional Manufacturer Narrative · 1

    AT THE MOMENT NO DEVICE FAILURE COULD BE IDENTIFIED. A USER ERROR (E.G. NEGLECTING CONTRAINDICATIONS, RISK FACTORS) CANNOT BE EXCLUDED. FURTHERMORE, WE HAVE HUNDREDS OF TRAINING SESSIONS EVERY DAY AROUND THE WORLD AND WE NEVER GOT SIMILAR FEEDBACKS SO FAR. THEREFORE, WE ASSUME THAT THE SPECIFIC PATIENT-SITUATION OR THE SETTING WAS NOT AS INTENDED ACCORDING TO THE INSTRUCTION FOR USE. AS THIS EVENT IS RELATED TO USER'S SAFETY, HOCOMA DECIDED TO INITIATE THIS INITIAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED DISCOMFORT TO WHOLE RIGHT LEG DURING TRAINING. THERAPIST ASKED PATIENT STRAP BY STRAP IF ANY OF THEM WERE BOTHERING HER, TO WHICH SHE ONLY RESPONDED YES TO THE UPPER THIGH STRAP WHICH THE THERAPIST LOOSENED SLIGHTLY. THERAPIST STOPPED TREATMENT AFTER 20 MINUTES EVEN THOUGH THE PATIENT WAS WANTING TO CONTINUE. UPON INSPECTION POST TREATMENT, PATIENT HAD INCREASED EDEMA TO THE LOWER LEG WITH DISCOLORATION THAT MATCHED THE AREA OF THE STRAP JUST BELOW THE KNEE AS WELL AS A KNOT JUST ABOVE WHERE THE ANKLE STRAP WAS. PATIENT SUBSEQUENTLY TRANSFERRED TO ACUTE CARE WITH A RIGHT LOWER EXTREMITY HEMATOMA AND HAD A COUPLE OF SURGICAL PROCEDURES TO EVACUATE HEMATOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204687 LOKOMAT SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK HOCOMA AG LOKOMATPRO L60183

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention