BEUDAMED
    FDA Adverse Event Other Summary report: N

    GETINGE INTRA AORTIC BALLOON

    MDR report key: 19212798 · Received April 29, 2024

    Report

    Report Number
    MW5154431
    Event Type
    Other
    Date Received
    April 29, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 25, 2024
    Manufacturer
    GETINGE USA SALES, LLC.
    Product Code
    DSP
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 56 YEAR-OLD-MALE UNDERWENT AN INTRA-AORTIC BALLOON PUMP (IABP) DUE TO CARDIOGENIC SHOCK. FOLLOWING THE PLACEMENT OF A GETINGE IABP AN ACUTE, TYPE B DISSECTION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131650 GETINGE INTRA AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP GETINGE USA SALES, LLC. MEGA 8FRX15CM 3000351644

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other