BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOSEAL

    MDR report key: 7953963 · Received October 10, 2018

    Report

    Report Number
    1416980-2018-06480
    Event Type
    Death
    Date Received
    October 10, 2018
    Report Date
    October 10, 2018
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT UNDERGOING BRAIN SURGERY FOR TUMOR REMOVAL WITH THE USE OF FIVE FLOSEAL UNITS IN CONJUNCTION WITH A CELL SAVER DEVICE EXPERIENCED CLINICAL SIGNS OF DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND SUBSEQUENTLY PASSED AWAY. THE DIC OCCURRED AFTER THE BLOOD FROM THE CELL SAVER DEVICE WAS REINTRODUCED INTO THE PATIENT. TREATMENT FOR THE DIC WAS NOT REPORTED. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794307 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death