BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1915796 · Received November 30, 2010

    Report

    Report Number
    3004464228-2010-01405
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    July 12, 2010
    Report Date
    November 3, 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 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 RECEIVED MEDICAL ATTENTION IN ORDER TO TREAT 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'S WIFE REPORTED THAT HER HUSBAND'S "INFUSION SITE BECAME INFECTED" AS A RESULT OF WEARING THE POD. THE SITE HAD TO BE "CUT OPEN AND DRAINED." NO ADDITIONAL INFO WAS PROVIDED REGARDING THE EVENT OR THE POD. NO PRODUCT WILL 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 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention