BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1851617 · Received September 29, 2010

    Report

    Report Number
    3004464228-2010-01298
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION. UNABLE TO CONFIRM ANY ISSUE RELATED TO THE POD'S ADHESIVE. 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 PATIENT 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 AND CONTACTED A PHARMACIST FOR SKIN BARRIER PRODUCT SUGGESTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER'S PHARMACIST CALLED TO REQUEST A LISTING OF PRODUCTS THAT COULD BE USED TO PROTECT THE CUSTOMER'S SKIN FROM THE POD ADHESIVE. THE CUSTOMER HAS RECENTLY DEVELOPED AN "IRRITATION OR RASH AS WELL AS DETERIORATION OF THE SKIN ON THE ENTIRE AREA OF THE POD ADHESIVE PATCH". CUSTOMER CARE REFERRED THE PHARMACIST TO THE OMNIPOD WEBSITE FOR SKIN BARRIER PRODUCT RECOMMENDATIONS AND STRONGLY ADVISED THAT THE USER CONTACT HER HEALTHCARE PROVIDER AND/OR DERMATOLOGIST FOR ADDITIONAL TREATMENT. 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 8 YR Other