BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL INTRODUCER SHEATH AND HEMOSTASIS

    MDR report key: 1906077 · Received October 12, 2010

    Report

    Report Number
    3004534947-2010-00004
    Event Type
    Death
    Date Received
    October 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MORRIS INNOVATIVE, INC.
    Product Code
    OEX
    PMA / PMN Number
    P050043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BLEEDING OCCURRED AROUND SHEATH, UNABLE TO ACHIEVE HEMOSTASIS WITH FISH DEVICE. FEMOSTOP WAS APPLIED TO PT. HEMATOMA APPROX THE SIZE OF A CANTALOUPE, DISSOLVED AWAY. PT WAS INITIALLY REPORTED AS OKAY. PTT WAS HIGH, THROMBOCYTOPENIA (NOT DEVICE RELATED). PT PASSED AWAY THE EVENING OF (B)(6) 2010; PROCEDURE RELATED. PT HAD DISSEMINATED INTRAVASCULAR COAGULATION (DIC). NOT DEVICE RELATED. PHYSICIAN STATED, PT WAS NOT IN GOOD CONDITION BEFORE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL INTRODUCER SHEATH AND HEMOSTASIS FISH OEX MORRIS INNOVATIVE, INC. 16-06-01-S 3498

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death