BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORT, IMPLANTABLE

    MDR report key: 1621498 · Received February 22, 2010

    Report

    Report Number
    1621498
    Event Type
    Death
    Date Received
    February 22, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 22, 2010
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPTED INSERTION OF A POWERPORT, THE PT. CODED. A CARDIAC TAMPONADE WAS DISCOVERED. DESPITE RESUSCITATIVE EFFORTS, THE PT. EXPIRED. THE CAUSE OF THE EVENT IS CURRENTLY UNKNOWN. THE PT'S BODY WAS RELEASED TO THE MEDICAL EXAMINER FOR AUTOPSY AND THE RESULTS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT, IMPLANTABLE PORT-A-CATH LJT BARD ACCESS SYSTEMS * RETL0549

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death