BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET

    MDR report key: 498216 · Received November 25, 2003

    Report

    Report Number
    3003442380-2003-00058
    Event Type
    Death
    Date Received
    November 25, 2003
    Date of Event
    October 20, 2003
    Report Date
    November 10, 2003
    Manufacturer
    MAERSK MEDICAL DEV. S.A. DE C.V.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003 THE MEDICAL EXAMINER CALLED MEDTRONIC MINIMED TO REQUEST TO LOOK FOR A LETTER OF ANALYSIS. IT STATES THAT THE CUSTOMER PASSED AWAY IN 2003. CAUSE UNKNOWN. THE END USER WAS WEARING THE PUMP AT THE TIME OF DEATH. ON 11/2003 UNOMEDICAL RECEIVED THE COMPLAINT AND 1 USED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET SUBCUTANEOUS INFUSION SET FOZ MAERSK MEDICAL DEV. S.A. DE C.V. 23"-6MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death INSULIN, INSULIN PUMP.