BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET MARILYN

    MDR report key: 440058 · Received January 15, 2003

    Report

    Report Number
    75862-2003-00020
    Event Type
    Malfunction
    Date Received
    January 15, 2003
    Date of Event
    September 18, 2002
    Manufacturer
    MAERSK MEDICAL DEV. S.A. DE C.V.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BENT CANNULA WITH HYPERGLYCEMIA. ON 01/08/2002 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 DEV. S.A. DE C.V. 23" 6MM 532613

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 1) INSULIN, 2) INSULIN PUMP.