BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3120233 · Received May 20, 2013

    Report

    Report Number
    3004753838-2013-00130
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 20, 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 ON (B)(6) 2013, ONE DAY AFTER SENSOR INSERTION, PATIENT EXPERIENCED A RASH UNDER THE SENSOR ADHESIVE. THE RASH SPREAD BEYOND THE EDGES OF THE SENSOR ADHESIVE AND CAUSED SCARING. PATIENT REPORTS THAT SHE IS ALLERGIC TO OTHER MEDICAL ADHESIVES. PATIENT CONSULTED WITH HER HUSBAND, A PHYSICIAN. HE RECOMMENDED SHE USE CORTISONE CREAM FOR THE ISSUE. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED THAT HER RASH WAS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221607 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5054705

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other