BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC400-14

    MDR report key: 740415 · Received July 22, 2005

    Report

    Report Number
    1221261-2005-00013
    Event Type
    Malfunction
    Date Received
    July 22, 2005
    Date of Event
    July 5, 2005
    Report Date
    July 22, 2005
    Manufacturer
    MRJ
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF SAMPLE FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A RADIOLOGICAL EXAMINATION (COMPUTED TOMOGRAPHY) THE BLOCKED CATHETER RUPTURED INTRA URETHRAL. THE REMNANT PART OF THE CATHETER HAD TO BE REMOVED BY CYSTOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC400-14 FOLEY CATHETER TEMPERATURE SENSOR KOD MRJ FC400-14 200408A(ESTIMATED)

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR