BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABORIE T-DOC-7FD

    MDR report key: 8662250 · Received June 3, 2019

    Report

    Report Number
    8662250
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 29, 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 BLUETOOTH 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
    455073 LABORIE T-DOC-7FD DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC T-DOC-7FD 181680

    Patients

    Seq Age Sex Outcome Treatment
    1