BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUFILL

    MDR report key: 5100073 · Received September 24, 2015

    Report

    Report Number
    5100073
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 18, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUSPECTED ALLERGIC REACTION TO THE GLUE INJECTED TO SEAL ANEURYSM, STRIDOR BREATHING NOTED AND PATIENT BECAME UNRESPONSIVE, ECHO CONFIRMED CARDIAC STANDSTILL. MANUFACTURER RESPONSE FOR TRUFILL LIQUID EMBOLIC SYSTEM, TRUFILL LIQUID EMBOLIC SYSTEM (PER SITE REPORTER): MANUFACTURER REP WAS PRESENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631558 TRUFILL DEVICE, NEUROVASCULAR EMBOLIZATION HCG CODMAN & SHURTLEFF, INC. 635125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death