BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEFLON COATED FOLEY CATHETER

    MDR report key: 175207 · Received July 2, 1998

    Report

    Report Number
    9610849-1998-00014
    Event Type
    Injury
    Date Received
    July 2, 1998
    Report Date
    June 3, 1998
    Manufacturer
    KELSAR, S.A.
    Product Code
    FCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EIGHT YEAR OLD WAS UNDERGOING AN X-RAY PROCEDURE. DURING PRETEST THE CATHETER WORKED FINE. ONCE THE CATHETER WAS PLACED, AN EXPERIENCED CLINICIAN COULD NOT REMOVE THE CATHETER. FIRST A SYRINGE WAS USED, THEN THE CLINICIAN TRIED CUTTING. BOTH WERE UNSUCCESSFUL. A CYSTOSCOPE WAS PERFORMED AND THE FOLEY WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEFLON COATED FOLEY CATHETER FOLEY CATHEER FCN KELSAR, S.A. NA 898714

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention