BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET MARILYN

    MDR report key: 440796 · Received January 30, 2003

    Report

    Report Number
    75862-2003-00026
    Event Type
    Injury
    Date Received
    January 30, 2003
    Date of Event
    December 13, 2002
    Report Date
    January 30, 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 Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSP, AND PT FOUND A LEAK UNDER THE RESERVOIR AT THE RESERVOIR COMPARTMENT. ON 01/23/2003 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED SET.

    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 2200056

    Patients

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