BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 2619037 · Received March 6, 2009

    Report

    Report Number
    2915056-2009-00002
    Event Type
    Injury
    Date Received
    March 6, 2009
    Date of Event
    February 26, 2009
    Report Date
    February 26, 2009
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, A (B)(6) MALE PT WAS SCHEDULED FOR SEED IMPLANTATION. THE REPORTER EXPERIENCED A HIGHER THAN BACKGROUND ACTIVITY IN A CARTRIDGE MANUFACTURED BY MICK RADIO-NUCLEAR INSTRUMENTS LOADED WITH IODINE I-125 SEEDS, MODEL 6711, 0.324 MCI CALIBRATED FOR 20(B)(6) 2009, MANUFACTURED BY GE HEALTHCARE. THE PRODUCT WAS SOLD AS A STERILE CONVENIENCE PACK (BATCH (B)(4)). THERE WAS NO CONTAMINATION FOUND PRIOR TO THE IMPLANT. THE UROLOGIST DID NOT EXPERIENCE ANY PROBLEMS (SUCH AS RESISTANCE) WITH THE APPLICATOR OR CARTRIDGE DURING THE IMPLANT PROCEDURE. AS THE SEEDS WERE BEING IMPLANTED INTO THE PT AND APPROXIMATELY 2/3 OF THE WAY THROUGH THE PROCEDURE, AN EMPTY CARTRIDGE WAS PASSED BACK AND SURVEYED. THE SURVEY INDICATED HIGHER (ACTIVITY NOT SPECIFIED) THAN BACKGROUND ACTIVITY. THE UROLOGIST WAS CONCERNED THAT ONE OF THE SEEDS LEAKED IN THE CARTRIDGE AND THE LEAKING SEED WAS NOW IMPLANTED INTO THE PT. THE PT WAS PLACED ON THYROID BLOCKING MEDICATION. BLOOD SAMPLES SHOWED A SLIGHTLY HIGHER THAN BACKGROUND ACTIVITY (ACTUAL ACTIVITY NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODINE (I-125) SEEDS NONE KXK GE HEALTHCARE 6711 KW9013A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention NO CONCOMITANT DRUGS REPORTED.