BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1831917 · Received September 7, 2010

    Report

    Report Number
    3005168196-2010-00590
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE DEVICE IS BROKEN AT THE BEGINNING OF THE SPIRAL IN THE STRAIN RELIEF. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: DUE TO THE ABSENCE OF THE CHIP BOARD SHIPPING BOXES IT IS IMPOSSIBLE TO SAY WHETHER THE DAMAGE OCCURRED DURING SHIPPING OR SUBSEQUENT HANDLING. THE DAMAGE SEEN IS CONSISTENT WITH THE EVENTS REPORTED. 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 NEURONS WERE FOUND DAMAGED IN THEIR PACKAGES PRIOR TO ANY USE. THIS MDR IS ASSOCIATED WITH MDR3005168196-2010-00591 AND MDR3005168196-2010-00592.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F16565

    Patients

    Seq Age Sex Outcome Treatment
    1