BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURA VALVE

    MDR report key: 359329 · Received October 23, 2001

    Report

    Report Number
    2518608-2001-00008
    Event Type
    Other
    Date Received
    October 23, 2001
    Report Date
    October 22, 2001
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SHUNT WAS RETURNED TO THE DISTRIBUTOR AFTER BEING IMPLANTED IN A TWO MONTH OLD INFANT AND REMOVED AT THE TIME OF REVISION ( A WEEK LATER DUE TO MALFUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47620 ACCURA VALVE HYDROCEPHALUS SHUNT JXG PHOENIX BIOMEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other