BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2013686 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00050
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THE CUSTOMER HAD TWO INSTANCES WHERE THEY HAD TO THROW THE CATHETER AWAY DUE TO KINKING; NOTICED AS IT WAS REMOVED FROM THE PACKAGE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00420 WHICH PERTAINS TO THE (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1