BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-DOC

    MDR report key: 4645901 · Received February 27, 2015

    Report

    Report Number
    9681424-2015-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    November 13, 2014
    Report Date
    February 26, 2015
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CANADA ULC
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT FROM (B)(6) COMPETENT AUTHORITY FOR MEDICAL DEVICES WAS IN (B)(4) LANGUAGE, DIFFICULT TO UNDERSTAND AND PROVIDED LIMITED INFORMATION. ONCE WE RECEIVED BACK THE CATHETER ON FEBRUARY 19, 2015 WE WERE ABLE TO DETERMINE THIS INS A REPORTABLE EVENT. THE URODYNAMIC CATHETER RETURNED IS MISSING 8 CENTIMETERS (3.15 INCHES) OR LENGTH FROM THE URETHRAL PRESSURE SENSOR BALLOON TO THE DISTAL TIP OF THE CATHETER. WILL FOLLOW UP WITH CUSTOMER TO DETERMINE IF A RIGID SCOPE AND/OR ANY SURGICAL DEVICE OR INSTRUMENT WAS USED AT ANY TIME DURING THE URODYNAMIC PROCEDURE, INCLUDING DURING CATHETER INSERTION AND CATHETER WITHDRAWAL. THIS TO ENSURE THE CATHETER WAS NOT DAMAGED BY OTHER MEANS AT THE CUSTOMER'S LOCATION.

    Description of Event or Problem · 1

    DURING URODYNAMIC DIAGNOSTIC PROCEDURE, THEN THE URODYNAMIC CATHETER WAS WITHDRAWN FROM THE PATIENT'S BLADDER, THE SENSOR WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140318 T-DOC 7FR DUAL SENSOR CATHETER FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC T-DOC-7FD 130912

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR