BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1882235 · Received October 20, 2010

    Report

    Report Number
    3004464228-2010-01327
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 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 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 WILL BE MEETING WITH A CLINICAL SPECIALIST TO HELP RESOLVE THIS SKIN ISSUE. 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 PLAYS SPORTS AND HAS DIFFICULTY WITH THE PODS STAYING ON. HE TRIED USING MASTISOL, WHICH "WAS WORKING GREAT", BUT HAD RESULTED IN A BAD RASH - HE LATER FOUND OUT THAT IT WAS AN ALLERGIC REACTION. HE IS PLANNING ON MEETING WITH A CLINICAL SPECIALIST TO ASSIST IN FINDING A RESOLUTION TO THIS SKIN REACTION. 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 20 YR Other