BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 112939 · Received August 8, 1997

    Report

    Report Number
    MW1011876
    Event Type
    Malfunction
    Date Received
    August 8, 1997
    Date of Event
    July 31, 1997
    Report Date
    August 7, 1997
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER TO BE USED FOR SHUNT WAS TESTED PRIOR TO INSERTION AND FOUND NOT TO HAVE SLITS. ANOTHER CATHETER FROM THE SAME LOT WAS USED WITHOUT INCIDENT. DEFECTIVE CATHETER WAS NEVER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant PEDIATRIC NEONATAL CATHETER JXG PHOENIX BIOMEDICAL CORP. * E1 557

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR