BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC SEALANT

    MDR report key: 312326 · Received January 12, 2001

    Report

    Report Number
    2952600-2001-00001
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    August 25, 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 8/2000, THE PT, DEVELOPED TRANSIENT ISCHEMIC ATTACKS (TIA) POSTOPERATIVELY FOLLOWING A CAROTID ENDARTERECTOMY (CEA) PROCEDURE TO TREAT STENOSIS OF THE CAROTID ARTERY. THE PT WAS TREATED WITH AN ANTICOAGULANT (ASPIRIN) AND RECOVERED WITHOUT FURTHER COMPLICATIONS. FLOSEAL MATRIX HEMOSTATIC SEALANT WAS REPORTEDLY USED DURING THE CEA PROCEDURE TO ACHIEVE INTRA-OPERATIVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592 FLOSEAL HEMOSTATIC SEALANT STERILE HEMOSTATIC SEALANT KIT LMF FUSION MEDICAL TECHNOLOGIES, INC. NA 000915

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention