BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR-CHARGED SINGLE SENSOR COUDÉ CATHETER

    MDR report key: 14266036 · Received May 3, 2022

    Report

    Report Number
    14266036
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    January 31, 2022
    Report Date
    April 20, 2022
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Product Code
    FEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AIR CHARGED SINGLE SENSOR COUDE CATHETER INSERTED INTO PATIENTS PENIS FOR URODYNAMIC ASSESSMENT. BLOOD FROM PENIS NOTED BY THE R.N. PERFORMING THE PROCEDURE AFTER INSERTION. THE PATIENT WAS NOT BLEEDING PRIOR TO THE INSERTION OF DEVICE. THE R.N. WAS CONCERNED UPON SEEING THE BLEEDING AND PROCEEDED TO WITHDRAWAL THE CATHETER. THE R.N. THEN OBSERVED A SHARP, EXPOSED CURVED WIRE PROTRUDING FROM THE END OF THE CATHETER. THE R.N. THEN NOTIFIED THE M.D., CHARGE R.N., AND NURSE MANAGER. ASSESSMENT BY CLINICAL STAFF WAS SMALL BLEEDING FROM PENIS. PATIENT WAS INFORMED TO MONITOR FOR WORSENING BLEEDING, INCREASE FLUIDS, AND CALL THE UROLOGY FOR WORSENING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217920 AIR-CHARGED SINGLE SENSOR COUDÉ CATHETER DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CAT878 214475

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Male Other