BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1842627 · Received September 1, 2010

    Report

    Report Number
    3005168196-2010-00597
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 6, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS AVAILABLE FOR EVALUATION AND A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE WAS DAMAGED UPON DELIVERY AND THE KINK WAS NOTICED PRIOR TO OPENING. THE PRODUCT WAS NOT USED.

    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