BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX DIAMOND VALVE

    MDR report key: 328288 · Received April 10, 2001

    Report

    Report Number
    2518608-2001-00004
    Event Type
    Other
    Date Received
    April 10, 2001
    Date of Event
    March 1, 2001
    Report Date
    April 10, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VALVE WAS RETURNED TO MANUFACTURER WITH NO INFORMATION ON THE VALVE. PATIENT, COMPLAINT, OR THE MEANS OF DIAGNOSING THE PROBLEM. MANUFACTURER HAS TRIED TWICE ALREADY TO GAIN MORE INFORMATION, WITH NO AVAIL.

    Description of Event or Problem · 1

    NEVER REC'D EXPLANATION OF EVENT FROM HOSPITAL OR DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16851 PHOENIX DIAMOND VALVE HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP. NA B34

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other