BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 2093337 · Received April 19, 2011

    Report

    Report Number
    3005168196-2011-00151
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE NEURON DELIVERY CATHETER 053 WAS REMOVED FROM THE PACKAGING AND THE NEURON SEPARATED ABOUT 10 INCHES FROM THE DISTAL TIP. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 DQY PENUMBRA, INC. F13266

    Patients

    Seq Age Sex Outcome Treatment
    1