BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 312380 · Received January 12, 2001

    Report

    Report Number
    2952600-2001-00002
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    October 24, 2000
    Report Date
    December 15, 2000
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 10/2000, THE PT, DEVELOPED A STROKE POSTOPERATIVELY AS A RESULT OF EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY. PRIOR TO THE EVENT, FLOSEAL MATRIX HEMOSTATIC SEALANT WAS REPORTEDLY USED IN THE CAROTID ENDARTERECTOMY (CEA) PROCEDURE PERFORMED ON THE PT TO TREAT STENOSIS OF THE CAROTID ARTERY. THIS COMPLICATION WAS NOT RESOLVED WITH ANTICOAGULANT THERAPY. THE PT HAD NOT RECOVERED FROM THE STROKE AT THE TIME OF THIS REPORT (12/15/2000). DURING THE PROCEDURE, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED USING FLOSEAL MATRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517 FLOSEAL MATRIX HEMOSTATIC SEALANT STERILE HEMOSTATIC SEALANT KIT LMF FUSION MEDICAL TECHNOLOGIES, INC. NA 000915

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other