BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD

    MDR report key: 2613386 · Received May 1, 2009

    Report

    Report Number
    2613386
    Event Type
    Death
    Date Received
    May 1, 2009
    Date of Event
    November 9, 2007
    Report Date
    April 27, 2009
    Manufacturer
    MEDRAD INC
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLUNGER IN THE SYRINGE BECAME DISLODGED SOMETIME DURING THE PROCESS OF ADMINISTERING THE CONTRAST MEDIA VIA THE MEDRAD INJECTOR INTO THE PT THROUGH A PERIPHERAL LINE. NO IMMINENT ISSUES WERE NOTED DURING OR IMMEDIATELY AFTER THE PROCEDURE. HOWEVER, 20 MINUTES AFTER RETURNING TO THE ER THE PT BECAME OBTUNDED AND NON RESPONSIVE. A CODE WAS CALLED - MULTIPLE EFFORTS FOR RESUSCITATION WERE ATTEMPTED WITHOUT SUCCESS. INITIALLY THE CORONER NOTED HER DEATH AS NATURAL BUT AFTER FURTHER REVIEW STATED DEATH DUE TO AN AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD ANGIOGRAPHIC CONTRAST MEDIA INJECTOR IZQ MEDRAD INC MARK IV

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death