BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEKRMD

    MDR report key: 20184964 · Received September 10, 2024

    Report

    Report Number
    3014250398-2024-00001
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 10, 2024
    Report Date
    September 9, 2024
    Manufacturer
    MATIA ROBOTICS (US), INC.
    Product Code
    IPL
    UDI-DI
    00811478030020
    PMA / PMN Number
    K191334
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE TRIAL USE, IT WAS OBSERVED THAT THE USER HAD MANUALLY ADJUSTED THE SPEED OF THE DEVICE AND ATTEMPTED A SHARP TURN AT A HIGH RATE OF SPEED. IT APPEARED THAT DURING THE TURN, THE USER ALSO MOVED THE JOYSTICK CONTROLLING THE SPEED AND DIRECTION OF THE DEVICE ABRUPTLY AND IN A DIRECTION CONTRARY TO THE OBSERVED DIRECTION OF TRAVEL. THESE FORCES CAUSED THE DEVICE TO TIP AND FALL ONTO THE FLOOR. EXAMINATION OF THE DEVICE FOUND THAT IT WAS NOT DAMAGED AND HAD NO SIGNS OF MALFUNCTION. IT WAS OBSERVED ON THE USER PANEL THAT THE SPEED CONTROL HAD BEEN ADJUSTED TO THE MAXIMUM SPEED SETTING - SIGNIFICANTLY HIGHER THAN INITIALLY SET BY THE SALESPERSON PRIOR TO THE USER TRIAL.

    Description of Event or Problem · 0

    THE USER ASKED TO USE THE TEK RMD TO EVALUATE ITS SUITABILITY. HE WAS INSTRUCTED ON THE SAFE USE OF THE DEVICE AND DID MEET THE CRITERIA FOR USER SUITABILITY AS DESCRIBED IN THE IFU. DURING THE TRIAL USE HE MADE A TURN AND FELL ONTO THE FLOOR. THE USER WAS IN THE DEVICE WHEN IT FELL TO THE MATTED SURFACE OF THE THERAPY GYM. THE DEVICE WAS LIFTED UPRIGHT BY THOSE WHO OBSERVED THE INCIDENT. THE USER WAS THEN ASSISTED TO GET OUT OF THE DEVICE. A SKIN TEAR WAS OBSERVED ON HIS ARM AND BRUISING WAS OBSERVED AT HIS HIP. THE USER LEFT THE THERAPY GYM, AND HE STATED THAT HE WAS GOING TO A LOCAL HOSPITAL ER FOR EXAMINATION. AFTER THE EVENT, THE SALES REPRESENTATIVE WAS INFORMED BY THE THERAPY GYM MANAGER THAT THE USER HAD POSSIBLY BEEN DIAGNOSED WITH A HIP FRACTURE (DIAGNOSIS HAS NOT BEEN INDEPENDENTLY CONFIRMED AT THIS TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329510 TEKRMD TEK ROBOTIC MOBILIZATION DEVICE IPL MATIA ROBOTICS (US), INC. TEKRMD03 00811478030020

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H