BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 87101 · Received April 25, 1997

    Report

    Report Number
    1222008-1997-00055
    Event Type
    Death
    Date Received
    April 25, 1997
    Date of Event
    March 27, 1997
    Report Date
    March 28, 1997
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BALLOON LEAK WAS NOTED LESS THAN 24 HOURS AFTER INSERTION. THE IAB WAS REMOVED AND NOT REPLACED. THE PT WAS REPORTED TO HAVE EXPIRED DUE TO ILLNESS AND NOT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant INTRA AORTIC BALLOON DSP C.R. BARD, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death