BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM SEVEN SYSTEM SENSOR

    MDR report key: 3242769 · Received July 17, 2013

    Report

    Report Number
    MW5030972
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I INSERTED A DEXCOM CGNS SENSOR AS I HAVE DONE MANY TIMES OVER THE PAST 2 YEARS. AT INSERTION, WHICH WAS PAINLESS, I NOTICED A SENSITIVITY ON MY ABDOMEN. THIS GREW INTO PAIN AND I REMOVED THE SENSOR 4 HOURS LATER. THE INSERTION AREA BLED SIGNIFICANTLY. I APPLIED PRESSURE AND THE BLEEDING STOPPED. PAIN RESOLVED WITH REMOVAL. PAINFUL - CAUSED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332041 DEXCOM SEVEN SYSTEM SENSOR DEXCOM SEVEN SYSTEM SENSOR MDS DEXCOM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other INSULIN BY PUMP