BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM

    MDR report key: 7992267 · Received October 22, 2018

    Report

    Report Number
    2029214-2018-00879
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 22, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    HCG
    PMA / PMN Number
    K162704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE RELATED REGULATORY REPORTS 2029214-2018-00869, 2029214-2018-00870, 2029214-2018-00872, 2029214-2018-00873, 2029214-2018-00874, 2 029214-2018-00875, 2029214-2018-00877, 2029214-2018-00878. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834252 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA UNK-NV-AXIUM NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1