BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1903494 · Received November 16, 2010

    Report

    Report Number
    3004464228-2010-01369
    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

    THE POD 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. IT IS UNKNOWN WHAT METHOD OF PREVENTIVE CARE (I.E., SKIN BARRIER PRODUCTS) THE CUSTOMER HAD USED WHEN FIRST BECOMING AWARE OF HER SKIN CONDITION WITHIN THE FIRST THREE MONTHS OF POD WEAR, NOR IS IT KNOWN HOW SHE IS CURRENTLY TREATING THE CONDITION. THE OMNIPOD WEBSITE OFFERS 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 REPORTED THAT HER SKIN IS "IN BAD SHAPE" AFTER HAVING WORN PODS FOR THE PAST THREE MONTHS. SHE HAS "DARK PURPLE PATCHES" (LIKE A BRUISE OR A "BAD RUG BURN") ON HER SKIN FOR WEEKS AFTER THE PODS ARE REMOVED. WHEN SOME PODS ARE REMOVED, THE TOP LAYER OF SKIN REPORTEDLY "RIPS OFF." SCARS ON HER SKIN ARE LEFT AS A RESULT. 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 38 YR Other