BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1242923 · Received November 20, 2008

    Report

    Report Number
    1063481-2008-00028
    Event Type
    Death
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFO WILL BE PROVIDED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A SURGEON STATED THAT HE HAD LOST A PT DUE TO BIOGLUE "MEANDERING IN THE BODY AND ULTIMATELY OCCLUDING BRAIN VESSELS". HOWEVER, IT IS UNCLEAR AS TO WHAT WAS MEANT BY "MEANDERING IN THE BODY". THE SITE OF APPLICATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MFI CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death