BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1903493 · Received November 16, 2010

    Report

    Report Number
    3004464228-2010-01370
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL NOT BE RETURNED FOR EVALUATION. UNABLE TO CONFIRM ANY ISSUE RELATED TO THE POD'S ADHESIVE THAT MAY HAVE RESULTED IN THE CUSTOMER'S ADVERSE SKIN CONDITION. THE OMNIPOD USER GUIDE INSTRUCTS PATIENTS TO CHECK THE INFUSION SITE DAILY FOR SIGNS OF INFECTION SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT. IF THERE ARE SIGNS THAT THE SITE MAY BE INFECTED, THE PT IS ADVISED TO IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE, CONTACT A HEALTH CARE PROVIDER AND TREAT THE INFECTION ACCORDING TO THE HEALTH CARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS DIRECTED TO THE OMNIPOD WEBSITE FOR A RESOURCE GUIDE THAT INCLUDES A LISTING OF SKIN BARRIER PRODUCTS THAT CAN AID IN SKIN PROTECTION.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER CALLED TO REPORT THAT HER DAUGHTER IS STARTING TO DEVELOP AN ALLERGIC REACTION TOWARDS THE POD ADHESIVE. CUSTOMER SUPPORT DIRECTED HER TO THE OMNIPOD WEBSITE FOR A LISTING OF PRODUCTS THAT COULD BE USED TO HELP PREVENT THE RECURRENCE OF HER DAUGHTER'S SKIN CONDITION. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other