BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE 8 FR. 34 CC. IAB WITH ACCESSORIES-DOMESTIC

    MDR report key: 294912 · Received September 7, 2000

    Report

    Report Number
    2248146-2000-00014
    Event Type
    Injury
    Date Received
    September 7, 2000
    Date of Event
    March 26, 2000
    Report Date
    August 8, 2000
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 2000 AT 6:15 P. AND REMOVED AT 11:00 P.M. THE IAB DID NOT MALFUNCTION. THE PT HAD SEVERE BLEEDING AND A TRANSFUSION WAS REQUIRED. ALSO, THE PT HAD MINOR ISCHEMIA AND REMOVAL OF THE IAB WAS REQUIRED. THE IAB WAS NOT RETURNED TO DATASCOPE. SEVERE BLEEDING-TRANSFUSION/MINOR ISCHEMIA-RPT'D 8/8/00. DISCHARGED-PR'D 8/8/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 8 FR. 34 CC. IAB WITH ACCESSORIES-DOMESTIC INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0884-00-0008 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other