BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON-WI (DXA UNIT)

    MDR report key: 18102138 · Received November 8, 2023

    Report

    Report Number
    MW5147974
    Event Type
    Other
    Date Received
    November 8, 2023
    Report Date
    October 26, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KGI
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING AN INSPECTION IN THE RADIOLOGY DEPARTMENT OF (B)(6) HOSPITAL IN (B)(6), IT WAS DISCOVERED THAT THE FACILITY HAD RECENTLY PURCHASED A NEW DXA UNIT FROM HOLOGIC. UPON VERBAL DISCUSSION WITH THE RADIOLOGY DEPARTMENT MANAGER (B)(6), IT WAS DETERMINED THAT THE HOLOGIC TRAINING REPRESENTATIVE HAD INSTRUCTED THE DXA USERS TO PRACTICE SCANNING ON EMPLOYEES OF THE RADIOLOGY DEPARTMENT. UNDER THE INSTRUCTION OF THE HOLOGIC TRAINING REPRESENTATIVE, FIVE EMPLOYEES WERE EXPOSED TO RADIATION FOR TRAINING PURPOSES, WITHOUT A DOCTOR'S ORDER AND THE EXAMS WERE NOT READ BY A RADIOLOGIST. THE NAME OF THE HOLOGIC TRAINING REPRESENTATIVE COULD NOT BE LOCATED. COPY OF DXA TRAINING SCAN OF ONE EMPLOYEE HAS BEEN EMAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234779 HORIZON-WI (DXA UNIT) DENSITOMETER, BONE KGI HOLOGIC, INC. ASY-07185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown