BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT SCANNER

    MDR report key: 15113739 · Received July 26, 2022

    Report

    Report Number
    MW5111147
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 23, 2022
    Manufacturer
    UNK
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNNECESSARILY PRESCRIBED A CT SCAN, THEN RECEIVED SEVERE OVER EXPOSURE TO IONIZING RADIATION. IN OTHER WORDS I WAS UNNECESSARILY EXPOSED TO HIGH LEVELS OF IONIZING RADIATION DURING A CT BRAIN SCAN. WAS GIVEN MORE THAN TEN TIMES THE ABSORBED IONIZING RADIATION DOSE FOR A BRAIN SCAN AND WAS SCANNED AT THAT DOSE MULTIPLE TIMES IN ONE SITTING DUE TO A NEGLIGENT CT OPERATOR AND OLDER IMPROPERLY MAINTAINED AND IMPROPERLY CALIBRATED CT SCANNER. THIS ABSORBED IONIZING RADIATION OVER EXPOSURE TO MY BRAIN AT 15 PLUS MSV SCANNED MULTIPLE TIMES (INSIDE CT SCANNER FOR OVER 10 MINUTES) WHEN I ONLY SHOULD'VE BEEN SCANNED ONCE, HAPPENED AT THE (B)(6) HOSPITAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426463 CT SCANNER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other