BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-DOC AIR CHARGED DUALSENSOR CATHETER

    MDR report key: 9219010 · Received October 22, 2019

    Report

    Report Number
    9219010
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    March 20, 2019
    Report Date
    September 18, 2019
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CANADA ULC
    Product Code
    FEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    URINARY CATHETER WAS INSERTED INTO PATIENT'S BLADDER AND CONNECTED TO COMPUTER VIA BLUE TOOTH DEVICE. SENSOR READINGS WERE INCORRECT DURING CALIBRATION SO CATHETER WAS REPLACED. THE SECOND CATHETER WORKED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014128 T-DOC AIR CHARGED DUALSENSOR CATHETER DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC 7FD 181304

    Patients

    Seq Age Sex Outcome Treatment
    1