BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC PLUS EVD SYSTEM W/O REFLUX VALVE

    MDR report key: 2896819 · Received December 28, 2012

    Report

    Report Number
    2648988-2012-00058
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K030289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 INFORMATION.

    Description of Event or Problem · 1

    INS8302 HERMETIC EXTERNAL VENTRICULAR DRAINAGE (EVD) KNOB DOESN'T KEEP EVD ON IV POLE AND CONTROLLING LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC PLUS EVD SYSTEM W/O REFLUX VALVE NA JXG INTEGRA NEUROSCIENCES PR 1123114

    Patients

    Seq Age Sex Outcome Treatment
    1