BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOFIX PERICARDIUM

    MDR report key: 513004 · Received February 26, 2004

    Report

    Report Number
    1627803-2004-00001
    Event Type
    Injury
    Date Received
    February 26, 2004
    Date of Event
    December 17, 2003
    Report Date
    February 26, 2004
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CARDIOFIX PATCH WAS USED TO REPAIR THE RIGHT VENTRICULAR OUTFLOW TRACT IN A PATIENT. APPROX ONE YEAR POST OP, THE PATIENT DEVELOPED A LEFT CHEST MASS, WHICH APPEARED ON CARDIAC CATHERIZATION TO BE FALSE ANEURYSM. AT THE TIME OF REOPERATION, IT WAS DETERMINED THERE WAS A TRUE ANEURYSM OF THE CARDIOFIX PATCH. IT WAS EXPLANTED AND REPAIRED WITH ANOTHER PATCH. THE PATIENT WAS LAST REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOFIX PERICARDIUM PERICARDIAL PATCH DXZ CARBOMEDICS, INC. CF-412 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization