BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRUCIFORM VALVE SHUNT KIT - MEDIUM PRESSURE

    MDR report key: 294906 · Received September 7, 2000

    Report

    Report Number
    2518608-2000-00004
    Event Type
    Other
    Date Received
    September 7, 2000
    Date of Event
    July 25, 2000
    Report Date
    September 7, 2000
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE VALVE DIDN'T DRAIN THE CEREBIAL SPINAL FLUID PROPERLY. VALVE WAS REPLACED WITH V070, PT IS OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUCIFORM VALVE SHUNT KIT - MEDIUM PRESSURE HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP. NA H010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other