BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 1544746 · Received November 4, 2009

    Report

    Report Number
    2029214-2009-00283
    Event Type
    Malfunction
    Date Received
    November 4, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 6, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL AS WAS CONSUMED IN THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION. NO PT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2009-002832.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK