BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIF-SPHERES

    MDR report key: 528296 · Received May 27, 2004

    Report

    Report Number
    9710358-2004-00005
    Event Type
    Death
    Date Received
    May 27, 2004
    Date of Event
    May 13, 2004
    Report Date
    May 27, 2004
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVERAL HOURS AFTER IMPLANTATION PT DEVELOPED ACUTE RESPIRATORY DISTRESS. ADMITTED TO INTENSIVE CARE; SUBSEQUENTLY INTUBATED AND VENTILATED. DESPITE ATTEMPTS TO RESUSCITATE, PT DIES SAME DAY. EXACT CAUSE OF DEATH UNK AT THIS TIME, BUT MOST LIKELY CAUSE WOULD APPEAR TO BE ACUTE RESPIRATORY FAILURE OR ASPIRATION OF GASTRIC CONTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIF-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR-Y001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization