BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1993464 · Received February 8, 2011

    Report

    Report Number
    3004464228-2011-00055
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 10, 2011
    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 PODS WILL NOT BE RETURNED FOR EVALUATION. WE ARE 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 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. THE CUSTOMER FOLLOWED THESE INSTRUCTIONS PER THE USER GUIDE AND WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION. 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 ON TWO DIFFERENT OCCASIONS, HE HAD "CELLULITIS" FROM WEARING PODS. HE EXPERIENCED "DISCOMFORT, REDNESS AND SWELLING AT THE INFUSION SITE"; THERE WAS ALSO "DISCHARGE COMING OUT TOO." HE WAS PLACED ON ANTIBIOTICS AND IS "GETTING BETTER." 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 L30437

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention