BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 320061 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00006
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    October 5, 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 REPORTED INTERMITTENT ABDOMINAL PAIN FOLLOWING THERASPHERE TREATMENT. PT WAS BRIEFLY ADMITTED FOR PAIN FOR ONE DAY IN 9/2000. WHEN SEEN IN FOLLOW-UP (9/00) PT AGAIN COMPLAINED OF PERSISTENT ABDOMINAL PAIN AND PT WAS INSTRUCTED TO TAKE AXID TWICE DAILY AND MORPHINE EVERY 3-4 HOURS FOR SEVERAL DAYS. ON THE EVENT DATE, THE PT REPORTED LITTLE PAIN RELIEF ON THIS REGIMEN. PT UNDERWENT ENDOSCOPY ON EVENT DATE AND WAS FOUND TO HAVE GASTRIC AND DUODENAL ULCERS. AXID WAS DISCONTINUED AND PREVACID WAS STARTED. AT PT'S 10/00 FOLLOW-UP VISIT, THE PT REPORTED IMPROVEMENT IN THEIR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9540 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990004

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization