BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 319722 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00007
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    October 9, 2000
    Report Date
    March 1, 2001
    Manufacturer
    MDS NORDION, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS SYMPTOMS OF ABDOMINAL PAIN. WORK-UP SHOWED PARTIAL BOWEL OBSTRUCTION. PT ADMITTED AND UNDERWENT EXPLORATORY LAPAROTOMY, SIGMOID COLECTOMY AND LIVER BIOPSY ON THE EVENT DATE. AT SURGERY: TWO LARGE FRIABLE TUMORS WERE WRAPPED AROUND THE SIGMOID COLON, ADHERENT TO THE MESENTERY AND POSTERIOR ABDOMINAL WALL. PATHOLOGY SHOWED: 1) PELVIC TUMOR POSITIVE FOR METASTATIC CARCINOID; 2) SIGMOID COLON POSITIVE FOR METASTATIC CARCINOID IN THE PERICOLONIC FAT; 3) LIVER BIOPSY NEGATIVE FOR MALIGNANCY BUT WITH EVIDENCE OF EXTENSIVE NECROSIS. POST-OP THE PT HAD SYMPTOMS OF FEVER, CHILLS AND NIGHT SWEATS; PT'S PAIN WAS WELL CONTROLLED. PT GRADUALLY IMPROVED AND WAS DISCHARGED 6 DAYS AFTER EVENT DATE. DISCHARGE MEDS INCLUDED PERCOCET FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9471 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990004

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization