BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3980908 · Received July 21, 2014

    Report

    Report Number
    3004464228-2014-01031
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO ISSUES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED SITE INFECTION. THE POD WAS FOUND TO HAVE COMPLETED STERILITY WITHIN SPECIFICATION. QUALIFICATION AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER WEARING THE POD FOR LESS THAN 24 HOURS ON THER LEG SHE NOTICED THE BACKING OF THE POD WAS DIGGING INTO HER SKIN. THE SITE WAS VERY PAINFUL, RED AND HOT. THERE WAS ALSO LARGE BUMP SO SHE DECIDED TO REMOVE THE POD. ON (B)(6) 2014 SHE WENT TO SEE HER DOCTOR WHO PRESCRIBED HER WITH ANTIBIOTIC OF "KEFLEX" AND IBUPROFEN FOR HER SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426645 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40983

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other