BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 088 SYSTEM

    MDR report key: 2862781 · Received December 10, 2012

    Report

    Report Number
    3005168196-2012-00416
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. PRODUCT DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    A NEURON MAX CATHETER WAS OPENED FOR A PROCEDURE AND IT WAS NOTED THAT THE DISTAL TIP WAS DAMAGED. THE PRODUCT WAS DISCARDED AND NEVER ENTERED THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON MAX 088 SYSTEM DQY DQY PENUMBRA, INC. F29044

    Patients

    Seq Age Sex Outcome Treatment
    1