BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1644781 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00430
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND A COPY IS ATTACHED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-04 (LOT # L15725). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE LOT HAS PASSED ALL DIMENSIONAL REQUIREMENTS PER SPECIFICATION. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PRE REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE NEURON TIP WAS FOUND FLATTENED IN THE PACKAGE. THE PHYSICIAN REQUESTED IT BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15725

    Patients

    Seq Age Sex Outcome Treatment
    1