BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI IMPLANTED PORT

    MDR report key: 18926 · Received November 25, 1994

    Report

    Report Number
    18926
    Event Type
    Death
    Date Received
    November 25, 1994
    Date of Event
    November 22, 1994
    Report Date
    November 25, 1994
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PHYSICIAN WAS ATTEMPTING TO INSERT IMPLANTAL PORT A DRASTIC DROP IN BLOOD PRESSURE WAS NOTED BY ANESTHESIA. CHEST TUBE WAS INSERTED DRAINING BLOODY FLUID. CHEST WAS OPENED TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI IMPLANTED PORT Implant MRI IMPLANTED PORT LJT BARD ACCESS SYSTEMS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death