BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX DIAMOND VALVE

    MDR report key: 355176 · Received October 8, 2001

    Report

    Report Number
    2518608-2001-00007
    Event Type
    Other
    Date Received
    October 8, 2001
    Date of Event
    March 31, 2001
    Report Date
    October 8, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS RETURNED TO THE MFR FROM THE DISTRIBUTOR IN SEOUL, KOREA ON 08/2001. THE REPORT GIVEN WAS "NO DRAIN AFTER IMPLANTATION DIAMOND VALVE AND PC01 WITHOUT P01". THE VALVE WAS RETURNED WITH 4 OTHER VALVES THAT WERE ALSO REPORTED "NO DRAIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45250 PHOENIX DIAMOND VALVE HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP * B27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other