BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD MARK V PROVIS

    MDR report key: 948032 · Received November 16, 2007

    Report

    Report Number
    948032
    Event Type
    Death
    Date Received
    November 16, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 15, 2007
    Manufacturer
    MEDRAD, INC
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT MID-PROCEDURE OF A ROOT AORTOGRAM. ADDITIONAL CONTRAST FOR PROCEDURE PULLED FROM BOTTLE AND RECONNECTED TO LINE. DURING INJECTION, AIR NOTED TO BE IN THE LINE AND INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD MARK V PROVIS MEDRAD DXT MEDRAD, INC PRM 220 60 510

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death LOT# 70209. REF CATALOG NUMBER 150 F7-Q| MEDRAD STERILE DISPOSABLE SYRINGE