BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 621716 · Received July 15, 2005

    Report

    Report Number
    8022247-2005-00014
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    June 9, 2005
    Report Date
    June 15, 2005
    Manufacturer
    MDS NORDION
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 (30 DAYS POST TREATMENT) THE PATIENT PRESENTED AT THE ER WITH ABDOMINAL PAIN, NAUSEA AND VOMITING, JUDGED DIRECTLY RELATED TO THERASPHERE TREATMENT. EGD ON THAT DAY REVEALED SEVERE DUODENAL AND GASTRIC ULCERATION WITH RESULTING OUTLET OBSTRUCTION. TISSUE BIOPSY SUGGESTED INFLAMMATION AND SURFACE ULCERATION SECONDARY TO RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE RADIOACTIVE MICROSPHERES KXK MDS NORDION NI 5990019

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization