BEUDAMED
    FDA Adverse Event Death Summary report: N

    F1500 MON F NEW

    MDR report key: 1113504 · Received August 13, 2008

    Report

    Report Number
    1310379-2008-00006
    Event Type
    Death
    Date Received
    August 13, 2008
    Report Date
    July 15, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FLL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 8/11/08. AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED. MULTIPLE ATTEMPTS BOTH WRITTEN AND VERBAL HAVE BEEN MADE BY TYCO HEALTHCARE/KENDALL TO OBTAIN ADD'L INFO INTO THE ALLEGED PROBLEM WITHOUT SUCCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A THERMOMETER. THE CUSTOMER STATES THAT INACCURATE READINGS ON THIS UNIT LED TO PTS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F1500 MON F NEW THERMOMETER FLL TYCO HEALTHCARE/KENDALL 8884103700 LX0424579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death