BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE 8 FR. 40CC IAB WITH GLI

    MDR report key: 436019 · Received January 2, 2003

    Report

    Report Number
    2248146-2002-00009
    Event Type
    Death
    Date Received
    January 2, 2003
    Report Date
    November 27, 2002
    Manufacturer
    DATASCOPE CORP.
    Product Code
    KGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB FAILED. IN 2002, DATASCOPE WAS NOTIFIED THE IAB LEAKED. THE IAB WAS ENTRAPPED AND THE DOCTOR WAS NOT ABLE TO REMOVE THE IAB. IT WAS REPORTED BY THE CONTACT AT THE FACILITY THE PT WENT ON TO EXPIRE FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 40CC IAB WITH GLI * KGZ DATASCOPE CORP. 0684-00-0320 1217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death