BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS KIT SPVA B905S/BO19-10

    MDR report key: 1982677 · Received January 21, 2011

    Report

    Report Number
    3001587388-2010-00351
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 5, 2010
    Report Date
    January 20, 2010
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MANUFACTURER ON (B)(6) 2010. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.

    Description of Event or Problem · 1

    THEY COULD NOT CHANGE THE PRESSURE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS KIT SPVA B905S/BO19-10 HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK