BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 292440 · Received August 24, 2000

    Report

    Report Number
    6000072-2000-00061
    Event Type
    Injury
    Date Received
    August 24, 2000
    Date of Event
    July 28, 2000
    Report Date
    July 28, 2000
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CLAIMS THAT THE GRAFT WAS IMPLANTED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) REPLACEMENT. FOLLOWING THE PROCEDURE, THE PT DEVELOPED A DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC). THE DOCTOR HAS COMMENTED THAT THE DIC WAS NOT SPECIFICALLY RELATED TO THE HEMASHIELD GRAFT, BUT IS AN ADVERSE REACTION ATTRIBUTED TO THE AAA REPLACEMENT IN GENERAL. THERE WAS NO BLOOD LOSS THROUGH THE GRAFT REPORTED. THE GRAFT WAS LEFT IN. NOTE: THE PRODUCT CODE, BATCH NUMBER AND CONDITION OF THE PT ARE UNKNOWN AT THIS TIME. THE INCIDENT DATE IS UNKNOWN AT THIS TIME AND HAS BEEN APPROXIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT DSY BOSTON SCIENTIFIC WAYNE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening| O