BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2898191 · Received January 7, 2013

    Report

    Report Number
    3005168196-2013-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE DISCARDED BY LAB STAFF.

    Description of Event or Problem · 1

    THE PHYSICIAN REMOVED THE NEURON 070 FROM THE PACKAGING AND NOTED THAT THE PRODUCT WAS KINKED. ANOTHER NEURON 070 WAS SELECTED AND USED WITHOUT INCIDENT. THERE WAS NO PATIENT INVOLVEMENT OR INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7710 NEURON DELIVERY CATHETER 070 DQY DQY PENUMBRA, INC. F23938

    Patients

    Seq Age Sex Outcome Treatment
    1