BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 5 GBQ

    MDR report key: 372238 · Received January 17, 2002

    Report

    Report Number
    8022247-2002-00001
    Event Type
    Injury
    Date Received
    January 17, 2002
    Date of Event
    January 7, 2002
    Report Date
    January 15, 2002
    Manufacturer
    MDS NORDION
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SECOND THERASPHERE TREATMENT TODAY. FOLLOWING THE PROCEDURE, THE PATIENT BECAME AGITATED AND PULSE OXIMETRY DROPPED TO THE MID 80'S. PATIENT WAS PLACED ON 100% NRB AND THEIR PULSE OX INCREASED TO THE LOW 90'S. THE PATENT WAS SUCTIONED ORALLY FOR CLEAR SECRETIONS. HARD SUCTIONING INDUCED BLEEDING AND A LARGE AMOUNT OF BLOOD WAS ASPIRATED. FOLLOWING SUCTIONING THE PULSE OX INCREASED TO THE HIGH 90'S ON 100% NRB. THE PATIENT WAS INTUBATED AT THIS TIME TO SECURE THEIR AIRWAY. THE PATIENT WAS ADMITTED TO THE MICU FOR FURTHER OBSERVATION AND IS CURRENTLY STILL THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE 5 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION * 2990001

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R