BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES

    MDR report key: 441771 · Received December 17, 2002

    Report

    Report Number
    9710358-2002-00002
    Event Type
    Injury
    Date Received
    December 17, 2002
    Date of Event
    November 19, 2002
    Report Date
    December 9, 2002
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A (DOSE) BRACHYTHERAPY IMPLANT OF SIR-SPHERES INTO THE LIVER VIA (R) HEPATIC ARTERY IN 2002 TO TREAT KNOWN HEPATOCELLULAR CARCINOMA. THE LEFT HEPATIC ARTERY WAS OCCLUDED FROM PRIOR RESECTION. PT REPORTED UPPER ABDOMINAL DISTENTION AND DISCOMFORT. CT SHOWS A NEW MASS IN RIGHT LOWER LOBE OF LIVER 2.7 X 3.6 CM. IT ALSO SHOWS THICKENING OF TRANSVERSE COLON. THERE IS EVIDENCE OF THE PREVIOUSLY TREATED HEPATIC TUMORS. ASCITES IS PRESENT. THERE IS THICKENING OF THE WALL OF THE LARGE BOWEL WHICH MAY BE PART OF THE THIRD SPACING OR ELSE DUE TO RADIATION COLITIS. RADIATION COLITIS IS NOT A KNOWN SIDE EFFECT OF SIR-SPHERES THERAPY AND THEREFORE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR Y001 23900

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization QD MVI, CA.| CURRENT: ZYPREXA 5 QHS AMBIEN 5MG QHS NEXIUM 40MG