BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2935122 · Received January 23, 2013

    Report

    Report Number
    3004464228-2013-00060
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 26, 2012
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    PMA / PMN Number
    K042762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY DEFECT OR DEFICIENCY OF THE DEVICE COULD HAVE CONTRIBUTED TO THE PT'S ALLERGIC REACTION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA WERE MET. THE OMNIPOD USER GUIDE WARNS "DO NOT USE A POD IF YOU ARE SENSITIVE TO OR HAVE ALLERGIES TO ACRYLIC ADHESIVES OR HAVE FRAGILE OR EASILY DAMAGED SKIN," AND CAUTIONS "IF AN INFUSION SITE SHOWS SIGNS OF INFECTION IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE AT A DIFFERENT SITE. CONTACT YOUR HEALTHCARE PROVIDER AND TREAT THE INFECTION ACCORDING TO INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE PT REPORTED THAT HIS SKIN WAS TURNING PURPLE AND SWOLLEN AT THE INSERTION SITE AFTER WEARING THE POD FOR LESS THAN A DAY. HE VISITED THE EMERGENCY ROOM ON (B)(6) 2012 AND WAS TREATED WITH ANTIBIOTICS AND A STEROID FOR AN ALLERGY TO THE CANNULA. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33188 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200 L31035

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other