BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 1400394 · Received June 6, 2009

    Report

    Report Number
    3001587388-2009-00122
    Event Type
    Injury
    Date Received
    June 6, 2009
    Date of Event
    May 13, 2009
    Report Date
    June 5, 2009
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MANUFACTURER IN 2009. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED IN VENTRICULO-PERITONEAL. THE VALVE WAS EXPLANTED BECAUSE OF A SUSPICION OF OBSTRUCTION. THE DOCTOR HAS REQUESTED TO CHECK THE VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK