BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3173595 · Received June 17, 2013

    Report

    Report Number
    3004753838-2013-00161
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT BEGINNING IN (B)(6) 2013, PATIENT HAS EXPERIENCED A RASH AND ITCHINESS UNDER THE SENSOR ADHESIVE PATCH. UPON REMOVAL OF THE MOST RECENT SENSOR ON (B)(6) 2013, PATIENT EXPERIENCED BLISTERING AND BLEEDING AT SENSOR SITE. PATIENT CONSULTED WITH A PHYSICIAN ON (B)(6) 2013. PHYSICIAN PRESCRIBED HYDROCORTISONE CREAM TO BE APPLIED AT THE SITE. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED THAT SITE IS RED BUT THAT SHE IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274653 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5059658

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other