BEUDAMED
    FDA Adverse Event Other Summary report: N

    ER

    MDR report key: 3075141 · Received April 19, 2013

    Report

    Report Number
    1119903-2013-00001
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS BTE POLICY TO REPORT TO THE FDA ANY EVENT INVOLVING BTE PRODUCTS THAT WE BECAME AWARE OF WHERE PATIENT OR USER REQUIRED MEDICAL INTERVENTION BY MEDICAL PERSONNEL. THIS REPORT IS SUBMITTED BECAUSE THE EQUIPMENT OPERATOR WAS EXAMINED BY A DOCTOR.

    Description of Event or Problem · 1

    TRAINED OPERATOR OF BTE EQUIPMENT WAS SETTING UP THE DEVICE TO PERFORM A PHYSICAL CAPABILITY TEST OF A POTENTIAL EMPLOYEE OF A FOOD DISTRIBUTION COMPANY. THE OPERATOR FAILED TO PROPERLY SECURE A HANDLE THAT IS PART OF THE DEVICE. THE OPERATOR PULLED ON THE HANDLE TO TEST THE SETUP. THE HANDLE CAME OUT AND THE OPERATOR FELL BACKWARD. THE OPERATOR HAD BRUISE ON THE ARM WHERE THE HANDLE HIT IT AND SORENESS IN THE BACK. X-RAY WAS PERFORMED AND ANTI-INFLAMMATORY MEDICINE GIVEN. THE DOCTOR DIAGNOSED IT AS A MILD CONCUSSION AND CERVICAL STRESS. ONE PERSON, THE OPERATOR, WAS INVOLVED IN THE INCIDENT. NO PATIENTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169166 ER IKK BTE TECHNOLOGIES, INC. ER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention