BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3920351 · Received July 8, 2014

    Report

    Report Number
    3004753838-2014-05756
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    June 10, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014, PATIENT EXPERIENCED A RASH AT SENSOR PATCH ADHESION SITE. MOTHER TREATED RASH WITH NEOSPORIN AND ALOE. PATIENT'S MOTHER SOUGHT MEDICAL INTERVENTION ON (B)(6) 2014 AND PATIENT WAS PRESCRIBED FLONASE FOR USE ON INSERTION SITE, UP TO 30 MINUTES PRIOR TO SENSOR INSERTION. NO FURTHER MEDICAL INTERVENTION WAS SOUGHT. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397501 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 MO Other