BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3925290 · Received July 2, 2014

    Report

    Report Number
    3004464228-2014-00915
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT QUALIFICATION OR STERILIZATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE BELIEVES THE INFUSION SITE IS INFECTED BECAUSE IT HURT A LOT, AN IT WAS RED, RAISED, WARM TO THE TOUCH, AND PUS WAS DRAINING OUT OF THE SITE. THE CUSTOMER CALLED FROM THE DOCTOR'S OFFICE AND HAD NOT YET SEEN THE DOCTOR. NO FURTHER INFORMATION REGARDING DIAGNOSIS OR TREATMENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385378 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other