BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 176511 · Received July 9, 1998

    Report

    Report Number
    2248146-1998-00720
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    April 1, 1998
    Report Date
    June 10, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTRA AORTIC BALLOON WAS INSERTED INTO THE PT ON 3/31/1998 AT 4:31 P.M. AND REMOVED ON 4/1/1998 AT 12:10 A.M. THE INTRA AORTIC BALLOON DID NOT MALFUNCTION. THE PT HAD MAJOR ISCHEMIA. REMOVAL OF THE INTRA AORTIC BALLOON WAS REQUIRED AND SURGERY WAS REQUIRED. (EVENT COMPLICATIONS: MAJOR ISCHEMIA/REMOVAL OF INTRA AORTIC BALLOON/SURGERY REQUIRED-RPT'D 6/10/1998.) (PT'S CURRENT STATUS: DISCHARGED-RPT'D 6/10/1998.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention