BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX K-TUBE

    MDR report key: 414669 · Received September 4, 2002

    Report

    Report Number
    2518608-2002-00002
    Event Type
    Other
    Date Received
    September 4, 2002
    Report Date
    September 3, 2002
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 7/11/02, PHOENIX BIOMEDICAL WAS CONTACTED BY FACILITY CONCERNING THE STERILIZATION OF CD-19 (K-TUBE). A PT THAT HAD BEEN IMPLANTED WITH A PHOENIX K-TUBE WAS PRESENTING WITH HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX K-TUBE CUSTOM DEVICE REQUESTED BY HOSP JXG PHOENIX BIOMEDICAL CORP. * J0096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R