BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1872780 · Received October 12, 2010

    Report

    Report Number
    3004464228-2010-01310
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 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

    THE POD WILL NOT BE RETURNED FOR EVALUATION. UNABLE TO CONFIRM ANY ISSUE RELATED TO THE POD'S ADHESIVE. THE OMNIPOD USER GUIDE INSTRUCTS PTS 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. IN ADDITION, THE OMNIPOD WEBSITE LISTS SKIN BARRIER PRODUCTS THAT CAN BE USED WHEN APPLYING THE POD THAT MAY HELP TO PREVENT THIS TYPE OF SKIN CONDITION FROM RECURRING.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON "STARTED TO HAVE IRRITATION ON HIS SKIN THE SHAPE OF THE POD. "ALMOST IMMEDIATELY AFTER APPLICATION, THE POD SITE "STARTS TO ITCH" AND HAS A "BURNING SENSATION". IN ADDITION, SCABS WERE DEVELOPING ON THE SITE. AS A RESULT OF THE DISCOMFORT FROM THIS SKIN CONDITION, THE CUSTOMER "IS MESSING' WITH THE SITE, CAUSING THE POD TO LOOSEN AND FALL OFF. INSULET CUSTOMER CARE RECOMMENDED SKIN BARRIER PRODUCTS THAT MAY BE ABLE TO PREVENT THIS CONDITION FROM RECURRING. 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 6 YR Other