BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 623579 · Received July 29, 2005

    Report

    Report Number
    1219856-2005-00192
    Event Type
    Injury
    Date Received
    July 29, 2005
    Date of Event
    July 2, 2005
    Report Date
    July 25, 2005
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED SHEATHLESS IN 2005. THE NEXT DAY, BLOOD WAS OBSERVED IN THE HELIUM TUBING AND PUMP. THE IAB WAS EXCHANGED. THERE WERE NO REPORTED PT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IAB WAS INSERTED SHEATHLESS ON 07/2005. ON 07/2005, BLOOD WAS OBSERVED IN THE HELIUM TUBING AND PUMP. THE IAB WAS EXCHANGED. THERE WAS NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention