BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4925736 · Received July 15, 2015

    Report

    Report Number
    3004464228-2015-00277
    Event Type
    Death
    Date Received
    July 15, 2015
    Date of Event
    May 23, 2015
    Report Date
    July 8, 2015
    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

    NO PRODUCT WAS RETURNED FOR EVALUATION. NO PRODUCT MALFUNCTION WAS ALLEGED. NO QUALIFICATION RECORDS WERE REVIEWED; NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT HER HUSBAND HAD PASSED AWAY ON (B)(6) 2015. THERE WAS NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460459 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death