BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IODINE (I-125) SEEDS IN CARRIER

    MDR report key: 2684975 · Received August 1, 2012

    Report

    Report Number
    2915056-2012-00022
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    July 4, 2012
    Report Date
    July 10, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A MALE PT (AGE UNSPECIFIED) UNDERWENT AN IMPLANTATION OF IODINE (I-125) BRACHYTHERAPY SEEDS (BRACHYMESH). FIFTY SEEDS AT 12.136 MBQ (0.328 MCI)/SEED, (TOTAL ACTIVITY EQUALS 606.8 MBQ (16.4 MCI)) WERE IMPLANTED IN THE RIGHT LUNG. ON (B)(6) 2012, THE PT WAS ADMITTED INTO THE HOSPITAL. A CHEST-X-RAY REVEALED HYDROPNEUMOTHORAX IN THE RIGHT UPPER LOBE AND A COMPUTED TOMOGRAPHY (CT) SHOWED A CAVITY ABSCESS. A CT-GUIDED PERCUTANEOUS DRAINAGE OF THE ABSCESS WAS PERFORMED AND IT WAS NOTED THAT SOME SEEDS WERE DISPLACED FROM THE IMPLANT SITE. X-RAYS OF THE CHEST AND ABDOMEN REVEALED APPROX 38 SEEDS IN THE RIGHT LUNG AND THREE SEEDS IN THE LARGE INTESTINE. THE PT REPORTED THAT HE HAD BEEN COUGHING UP SEEDS. HE WAS INSTRUCTED TO SAVE THE TISSUES USED WHEN COUGHING. THESE WERE MONITORED TWICE DAILY FOR RADIOACTIVITY. TO DATE NO LOOSE SEEDS HAVE BEEN FOUND. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODINE (I-125) SEEDS IN CARRIER RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALTHCARE 6720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R