BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLSI SUBLIGUAL SENSOR

    MDR report key: 541613 · Received August 27, 2004

    Report

    Report Number
    541613
    Event Type
    Death
    Date Received
    August 27, 2004
    Date of Event
    July 20, 2004
    Report Date
    August 26, 2004
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    CCK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISCOVERED POSSIBLE PRODUCT LINK IN 08/04. INFECTIVE SUBLINGUAL PROBE WITH POSSIBLE ADVERSE PT OUTCOME. INVESTIGATION IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLSI SUBLIGUAL SENSOR PROBE FOR NELLCOR N-80 CAPNO PROBE SL CCK TYCO HEALTHCARE GROUP LP SLSI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Death