BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD GOLD 8X15CM

    MDR report key: 1660122 · Received April 14, 2010

    Report

    Report Number
    1660122
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 13, 2010
    Manufacturer
    MAQUET INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    IT IS POSSIBLE (ALTHOUGH HAS NOT BEEN DETERMINED) THAT THE VASCULAR GRAFTS OR OTHER COMPONENTS OF THIS PATIENT'S VASCULAR PROCEDURE MAY HAVE CAUSED THIS PATIENT'S ASPERGILLUS INFECTION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PATIENT'S ASPERGILLUS INFECTION MAY HAVE BEEN LINKED TO VASCULAR GRAFTS OR OTHER COMPONENTS OF VASCULAR SURGERY PROCEDURE.====================== MANUFACTURER RESPONSE FOR ALLOGRAFT, GRAFT HEMASHIELD 8X15CM======================MANUFACTURER IS INVESTIGATING.====================== MANUFACTURER RESPONSE FOR ALLOGRAFT, GRAFT HEMASHIELD SINGLE BRANCH 28X50X10======================MANUFACTURER IS INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD GOLD 8X15CM PROSTHESIS, VASCULAR GRAFT DSY MAQUET INC. M002020951080 *
    2 HEMASHIELD PLATINUM SINGLE BRANCH 28X50X10 PROSTHESIS, VASCULAR GRAFT DSY MAQUET, INC. M00202175828P0 *
    3 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG35155US *
    4 COSEAL SEALANT 4 ML SEALANT NBE BAXTER BIOSCIENCE 934071 *
    5 PTFE FELT PATCH, PTFE DSY BARD PERIPHERAL VASCULAR * HUTL0041 & HUTJ1319

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death