BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MON-A-THERM

    MDR report key: 668595 · Received September 19, 2005

    Report

    Report Number
    2936999-2005-00364
    Event Type
    Malfunction
    Date Received
    September 19, 2005
    Date of Event
    July 20, 2005
    Report Date
    August 22, 2005
    Manufacturer
    MALINCKRODT
    Product Code
    BZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUFF COVERING THE TUBES PERFORATED. DISTAL-END REMAINED IN THE PATTENT'S ESOPHEGUS WHEN THE TUBE WAS REMOVED. STAFF WAS ABLE TO RECOVER THE CUFF AND REMOVE IT. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MON-A-THERM ESOPHAGEAL STETHOSCOPE BZW MALINCKRODT 12FR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN