BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 207794 · Received January 26, 1999

    Report

    Report Number
    MW1015507
    Event Type
    Injury
    Date Received
    January 26, 1999
    Date of Event
    December 21, 1998
    Report Date
    January 15, 1999
    Manufacturer
    DATASCOPE CORP. CARDIAC ASSIST
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE MFR ON 03/05/1999: THE PRODUCT WAS DISCARDED BY THE FACILITY. THE REPORTED "AUGMENTATION DIFFICULTY" COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant INTRA AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIAC ASSIST 9.5 FRENCH 40CC *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening