BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 126581 · Received July 3, 1997

    Report

    Report Number
    126581
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    June 4, 1997
    Report Date
    June 30, 1997
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FLUID (CSF) COLLECTED AROUND SHUNT HARDWARE; MAY HAVE LEAKED OUT OF HOLE IN VENTRICULAR CATHETER RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX Implant SHUNT CATHETER RESERVOIR JXG PHOENIX BIOMEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Hospitalization| R