BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLS1 SUBLINGUAL SENSOR

    MDR report key: 551766 · Received August 18, 2004

    Report

    Report Number
    MW1033001
    Event Type
    Other
    Date Received
    August 18, 2004
    Report Date
    August 18, 2004
    Manufacturer
    TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIV.
    Product Code
    CCK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFECTIVE SUBLINGUAL PROBE POSSIBLE ADVERSE PT OUTCOME. INVESTIGATION IN PROCESS. POSTIVE CULTURES OF PROBE SAMPLES. REPORT WILL BE AMENDED AS NECESSARY UPON COMPLETION OF INVESTIGATON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLS1 SUBLINGUAL SENSOR SUBLINGUAL PROBE FOR NELLCOR N-80 CAPNOPROBE SL INSTRUMENT CCK TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIV. SLS1 SAMPLE LOTS: SS04121

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other