BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE

    MDR report key: 2182361 · Received July 11, 2011

    Report

    Report Number
    2648988-2011-00026
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    INTEGRA, ANASCO
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CEREBROSPINAL FLUID (CSF) FLOWED BACK INTO THE VALVE. THE PRODUCT CAME IN CONTACT WITH THE PT. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE NA JXG INTEGRA, ANASCO 1102782

    Patients

    Seq Age Sex Outcome Treatment
    1