BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1891316 · Received November 2, 2010

    Report

    Report Number
    3004464228-2010-01347
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 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 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. IT IS UNK WHAT FORM OF THERAPY WAS SOUGHT BY THE CUSTOMER IN ORDER TO TREAT THIS SKIN 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 HUSBAND REPORTED THAT HIS WIFE HAS A "LUMP" AT THE POD SITE THAT'S "THE SIZE OF A PEAR." HER SKIN WAS DESCRIBED AS BEING DISCOLORED ("BLACK AND BLUE") AND BLOOD WAS PRESENT AT THE INSERTION SITE. THIS OCCURRED FIVE HOURS AFTER A NEW POD WAS APPLIED. NO INFORMATION WAS PROVIDED AS TO HOW THE CUSTOMER TREATED THIS CONDITION. THE POD WILL NOT 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 L30385

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other