BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD

    MDR report key: 5774813 · Received July 1, 2016

    Report

    Report Number
    MW5063251
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    May 1, 2016
    Report Date
    July 1, 2016
    Manufacturer
    INSULET
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING THE OMNIPOD INSULIN PUMPS SINCE (B)(6) 2014 (28 MONTHS). SINCE EARLY (B)(6) 2016, I HAVE DEVELOPED SKIN RASHES AROUND THE AREA WHERE THE CANNULA ENTERS THE SKIN. I HAVE NOT MADE ANY CHANGES IN MY LIFE THAT COULD EXPLAIN THE SUDDEN REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419383 OMNIPOD OMNIPOD LZG INSULET POD-ZXB-425 L42239

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR