BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 319766 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00003
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    September 24, 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

    IN 9-00, THE PT HAD SYMPTOMS OF DIFFUSE ABDOMINAL PAIN, FEVER, CHILLS, NIGHT SWEATS & VOMITING. PT WAS ADMITTED 09-00. PHYSICAL EXAM REVEALED: DIFFUSELY TENDER LIVER, ASCITES & HEPATOSPLENOMEGALY. CT-ABDOMEN SHOWED BLOODLY ASCITES AND A POSSIBLE AREA OF LIVER NECROSIS. PT WAS PLACED ON ZOSYN FOR PRESUMED PERITONITIS. TWO DAYS LATER, THE ANTIBIOTICS WERE SWITCHED TO AFTRIAXONE & VANCOMYCIN. THE PT RECEIVED IV MORPHINE FOR THE ABDOMINAL PAIN. THE PT'S PAIN DECREASED SIGNIFICANTLY WITH THIS MEDICATION. THEN PT'S PAIN IMPROVED AND PT WAS DISCHARGED 6 DAYS LATER ON PERCOCET PRN AND OXYCODONE FOR PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9510 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization