BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD ANGIOGRAPHIC INJECTOR

    MDR report key: 645643 · Received November 8, 2005

    Report

    Report Number
    2520313-2005-00030
    Event Type
    Death
    Date Received
    November 8, 2005
    Date of Event
    October 14, 2005
    Report Date
    November 8, 2005
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED MEDRAD PROVIS INJECTOR IS SUSPECTED IN A PT DEATH. THE INJECTOR HAS BEEN IMPOUNDED UNDER A CORONER'S WARRANT AND THE UNIT REMOVED BY THE POLICE. MEDRAD HAS MADE SEVERAL ATTEMPTS TO OBTAIN SPECIFIC DETAILS ABOUT THIS INCIDENT. THE HOSP HAS BEEN UNWILLING TO RELEASE ANY ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD ANGIOGRAPHIC INJECTOR ANGIOGRAPHIC INJECTOR DXT MEDRAD, INC. PRM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death