BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX, AVM

    MDR report key: 1033191 · Received April 23, 2008

    Report

    Report Number
    2029214-2008-00076
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIAL OF ONYX WAS RETURNED FOR EVAL, BUT DID NOT CONTAIN ENOUGH OF THE EMBOLIC SOLUTION TO PERFORM TESTING. RADIO-OPACITY TEST WAS PERFORMED ON THE RETAINED SAMPLE FROM THE SAME LOT AND WAS FOUND TO BE WITHIN SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED ONYX COULD NOT BE VISUALIZED DURING INJECTION. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-080 3510511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention