BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 861808 · Received June 7, 2007

    Report

    Report Number
    2029214-2007-00056
    Event Type
    Injury
    Date Received
    June 7, 2007
    Date of Event
    March 13, 2007
    Report Date
    May 11, 2007
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TREATED WITH APPROXIMATELY 1.4 ML OF ONYX FOR BRAIN EMBOLIZATION. POST PROCEDURE, THE PATIENT DEVELOPED A RASH ON HER TRUNK AND SHORTNESS OF BREATH. THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization