BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUS

    MDR report key: 6802106 · Received August 17, 2017

    Report

    Report Number
    1119903-2017-00003
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 25, 2017
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    PMA / PMN Number
    K933611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INCIDENT IS USER ERROR: THE OPERATOR LOST BALANCE AND STUMBLED.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO CALIBRATE THE PRIMUS, THE PHYSICAL THERAPIST MISSED THE SLOT IN THE CALIBRATION BAR WHERE THE CALIBRATION WEIGHT SHOULD BE HUNG AND LOST BALANCE. SHE HIT HER FACE ON THE CALIBRATION BAR OR WEIGHT, BREAKING HER NOSE. SHE REQUIRED SURGERY AT THE ER AND MISSED A FEW DAYS OF WORK. AFTER RETURNING TO WORK, THE THERAPIST CALLED BTE CUSTOMER SUPPORT WITH QUESTIONS REGARDING THE EQUIPMENT, SHE THEN DESCRIBED THE INCIDENT. SHE STATED THAT SHE WAS DOING WELL AND WAS SUFFERING NO ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581411 PRIMUS PRIMUS ISD BTE TECHNOLOGIES, INC. PRIMUS+

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention