BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 728774 · Received June 27, 2005

    Report

    Report Number
    3001587388-2005-00017
    Event Type
    Other
    Date Received
    June 27, 2005
    Date of Event
    May 30, 2005
    Report Date
    June 24, 2005
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED DRY INSTEAD OF IN STERILE WATER. ANALYSIS HAS TO BE DONE.

    Description of Event or Problem · 1

    THIS VALVE WAS EXPLANTED FROM THE PATIENT IN 2005 REVISION. ADDITIONAL NARRATIVES ARE REQUIRED TO THE NEUROSURGEON. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA SOPHY(R) VALVE P0483

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR