BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6096131 · Received November 11, 2016

    Report

    Report Number
    3004464228-2016-03600
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 17, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DOCTORS VISIT FOR THE PATIENT'S SITE IRRITATION. LOT RELEASE AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM  USER GUIDE MODEL: UST400 14421-AW REV H / 2016 USING THE POD 5 / PAGE 44 LIVING WITH DIABETES 9 / PAGE 107. WARNING: DO NOT USE A POD IF YOU ARE SENSITIVE TO OR HAVE ALLERGIES TO ACRYLIC ADHESIVES, OR HAVE FRAGILE OR EASILY DAMAGED SKIN. WARNING: AT LEAST ONCE A DAY, USE THE PODS VIEWING WINDOW TO INSPECT THE INFUSION SITE. CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING IRRITATION DESCRIBED TO LOOK LIKE ECZEMA. POD SITE IS SWOLLEN, DARK RED, HAS NICKEL SIZE BLISTERS WITH DRAINAGE AND FEELS LIKE A BURN. CUSTOMER CONSULTED WITH DOCTOR AND WAS PRESCRIBED MOMETASONE FUROATE 0.1% CREAM. POD WORN LONGER THAN 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747019 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42510 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention