BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX DIAMOND II SHUNT SYSTEM

    MDR report key: 334663 · Received May 22, 2001

    Report

    Report Number
    2518608-2001-00005
    Event Type
    Other
    Date Received
    May 22, 2001
    Date of Event
    May 4, 2001
    Report Date
    May 22, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPOTED TO CO THAT IN MAY 2001 A SHUNT WAS IMPLANTED AND EXPLANTED 10 DAYS LATER. "THE CLAIM IS THAT THE VALVE DOESN'T DRAIN WELL."

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPOTED TO CO THAT IN MAY 2001 A SHUNT WAS IMPLANTED AND EXPLANTED 10 DAYS LATER. "THE CLAIM IS THAT THE VALVE DOESN'T DRAIN WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23896 PHOENIX DIAMOND II SHUNT SYSTEM HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP. NA C20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other