BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET MARILYN

    MDR report key: 432382 · Received December 2, 2002

    Report

    Report Number
    9680866-2002-00001
    Event Type
    Malfunction
    Date Received
    December 2, 2002
    Date of Event
    August 23, 2002
    Report Date
    November 27, 2002
    Manufacturer
    MAERSK MEDICAL DEV SA DE CV
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAS HAD TO USE 6 QS IN THE LAST 10 DAYS, AS BG'S ARE GOING HIGH. EACH TIME THE INFUSION SET WAS REMOVED THE CANNULA WAS BENT. PT HAS A LOT OF BODY FAT AND IS NEW TO INSERTION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET MARILYN SUBCUTANEOUS INFUSION SET FOZ MAERSK MEDICAL DEV SA DE CV 43" 6MM 2200063

    Patients

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