BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    MDR report key: 33695 · Received June 24, 1996

    Report

    Report Number
    MW4001358
    Event Type
    Malfunction
    Date Received
    June 24, 1996
    Report Date
    April 26, 1996
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST-OPERATIVE PT ON CARDIO-THORACIC SURGICAL INTENSIVE CARE UNIT COMPLAINED OF URETHRAL PAIN UPON REMOVAL OF CATHETER. CATHETER WAS IN PT FOR LESS THAN 24 HRS. PHYSICIAN REPORTED THE INABILITY TO COMPLETELY DEFLATE BALLOON. THIS MADE FOR A WASHBOARD EFFECT OR DEFECT WHICH WAS EXTREMELY PAINFUL FOR THE PT WHEN THE CATHETER IS WITHDRAWN ACROSS THE TENDER URETHRAL LINING UPON REMOVAL. THE SAME SITUATION WITH THE CATHETER CAN BE REPRODUCED BY INSERTING 5CC OF WATER INTO THE BALLOON AND THEN REMOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER WITH TEMPERATURE SENSOR FOLEY CATHETER WITH TEMPERATURE SENSOR KOD RESPIRATORY SUPPORT PRODUCTS, INC. FC400-18 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA