BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET MARILYN

    MDR report key: 440804 · Received January 30, 2003

    Report

    Report Number
    75862-2003-00025
    Event Type
    Injury
    Date Received
    January 30, 2003
    Date of Event
    November 18, 2002
    Report Date
    January 24, 2003
    Manufacturer
    MAERSK MEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALL THE QUICK SETS FROM THIS BOX DID NOT DELIVER INSULIN TO THE BODY, AS A RESULT THE PT SUFFERED HIGH BLOOD GLUCOSE. ON 01/23/2003 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 4 UNUSED SETS AND 2 USED SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET MARILYN SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL DEVICE S.A. DE C.V. 23" 6MM 532611

    Patients

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