BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONYX, AVM

    MDR report key: 706879 · Received August 27, 2005

    Report

    Report Number
    2029214-2005-00068
    Event Type
    Other
    Date Received
    August 27, 2005
    Date of Event
    July 4, 2005
    Report Date
    August 27, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF ARTERIOVENOUS FISTULA (AVF) WITH ONYX, THE PATIENT EXPERIENCED AN ANAPHYLACTIC SHOCK. AFTER TWO MINUTES OF RESUSCITATION, THE HEART RAN AGAIN AND THE PATIENT WAS SENT TO ICU FOR MANAGEMENT OF THE COMPLICATION THAT FOLLOWED THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE MICRO THERAPEUTICS, INC. NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 *