BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PET/CT

    MDR report key: 3610231 · Received February 3, 2014

    Report

    Report Number
    MW5034175
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    August 21, 2013
    Report Date
    February 2, 2014
    Manufacturer
    NATIONAL JEWISH DENVER
    Product Code
    KPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENTAL LUNG NODULE THAT HAS 2% CHANCE OF CANCER FOUND (B)(6) 2013 AND CONSULT (B)(6). I REPORTED WEIGHT LOSS TO (B)(6) ABOUT 8 WEEKS LATER (HEALTH ANXIETY) AND DOCTOR ORDERED PET/CT BODY NOT A JUSTIFIED EXAM. DID NOT BLOOD WORK OR ANY OTHER TESTS. DID NOT EXPLAIN RISKS TO ME IS A HIGH RAD HIGH CANCER RISK EXAM. DID NO BOOKWORK. AFTERWARD DOCTOR SAID IT WAS NOT WARRANTED. MINIMUM DOSE WAS NOT GIVEN. I KNOW AT (B)(6) AND HOSPITALS AROUND COUNTRY PET/CT CAN BE DONE 8 MSV. MINE WAS 29 MSV AND I AM MORE AFRAID NOW THAN I WAS BEFORE. ANY COMMENTS OR PUBLIC REVIEWS HAVE BEEN BLOCKED BY (B)(6) DESPITE THEIR DIRECTOR TELLING ME MY RISK IS MINUSCULE. IT IS SINCE WHAT MANY ATOMIC BOMB SURVIVORS RECEIVED. THEY KNEW OF PREVIOUS SCAN THEY CONSULTED ON AND STILL IRRADIATED ME WITH THAT AMOUNT. DID NOT TAKE IT INTO CONSIDERATION. PLEASE INVESTIGATE, I HAVE CHILDREN AND I AM WORRIED ABOUT CANCER FROM THIS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71233 PET/CT PET/CT KPS NATIONAL JEWISH DENVER

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| S