BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 404318 · Received July 10, 2002

    Report

    Report Number
    2954761-2002-00009
    Event Type
    Injury
    Date Received
    July 10, 2002
    Date of Event
    June 1, 2002
    Report Date
    June 10, 2002
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FLOSEAL MATRIX HEMOSTATIC SEALANT WAS USED BY A SURGEON DURING AN UNSPECIFIED CARDIAC SURGICAL PROCEDURE TO ACHIEVE HEMOSTASIS. POST-OPERATIVELY, THE PATIENT WAS TRANSFERRED TO CRITICAL CARE UNIT (CCU). SOME TIME LATER (TIME UNKNOWN), THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO ADDRESS POST-OPERATIVE BLEEDING. THE SURGEON REPORTED THAT BLEEDING WAS FROM THE SAME SPECIFIC HOLE WHERE FLOSEAL HAD BEEN APPLIED EARLIER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention