BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1822769 · Received August 27, 2010

    Report

    Report Number
    3004464228-2010-01261
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 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 EVALUATION. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. 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 CONDITION ACCORDING TO THE HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER FOLLOWED THESE INSTRUCTIONS PER THE USER GUIDE AND WENT TO VISIT WITH A DERMATOLOGIST IN ORDER TO TREAT THE SKIN CONDITION.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE CUSTOMER EXPERIENCED AN ALLERGIC REACTION TO THE POD ADHESIVE. WHEN THE POD WAS REMOVED, THERE WAS "RED IRRITATION" AND A "POD SHAPED RASH" AT THE SITE. HE ALSO STATED THAT THE ADHESIVE WAS "RIPPING THE SKIN OFF OF THE SITE." AS A RESULT, HE WENT TO THE DERMATOLOGIST FOR TREATMENT. THE CUSTOMER HAD BEEN USING AN OVER-THE-COUNTER DRESSING, BUT THE SKIN CONDITION PERSISTED NONETHELESS. 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 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other