BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 2884879 · Received December 4, 2012

    Report

    Report Number
    3001587388-2012-00422
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WILL BE ANALYZED BY OUR LABORATORY, AND THE ANALYSIS WILL BE DEVELOPED IN F/U REPORT.

    Description of Event or Problem · 1

    POLARIS ADJUSTABLE VALVE WAS EXPLANTED AFTER ALTERNATIVE PERIOD OF HYPODRAINAGE AND OVERDRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA POLARIS Y0507

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR