BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1903508 · Received November 16, 2010

    Report

    Report Number
    3004464228-2010-01360
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 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 EVAL. 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 WILL BE MEETING WITH A CLINICAL SPECIALIST TO REVIEW PROPER POD APPLICATION TECHNIQUE TO PREVENT THE RECURRENCE BLISTERING AT THE POD SITE. 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 THE POD WAS WORN FOR LESS THAN A DAY AND WHEN IT WAS REMOVED, SHE NOTICED A "BLISTER OF ABOUT TWO INCHES IN DIAMETER." INSULET CUSTOMER SUPPORT DIRECTED THE CUSTOMER TO THE OMNIPOD WEBSITE FOR A LISTING OF SKIN BARRIER PRODUCTS. IN ADDITION, SHE REQUESTED A "REFRESHER COURSE" WITH A CLINICAL SPECIALIST TO REVIEW POD PLACEMENT TECHNIQUE TO PREVENT THE RECURRENCE OF THE BLISTERING. THE POD WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30328

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other