BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11497564 · Received March 16, 2021

    Report

    Report Number
    3004753838-2021-50337
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    April 20, 2020
    Report Date
    March 16, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VOLUNTARY MEDWATCH REPORT NUMBER MW5098969 LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION).

    Description of Event or Problem · 1

    HOD FOR AB 3.16IT WAS REPORTED THAT A SKIN REACTION OCCURRED. DATE OF ISSUE IS AN APPROXIMATION. THE PATIENT EXPERIENCED A SKIN REACTIONS TO THE SENSOR ADHESIVE. ITCHING STARTED AFTER SENSOR WAS INSERTED. THE PATCH WAS REMOVED AND THE SKIN HAD A BURNED APPEARANCE, AND THE PATIENT SELF-TREATED THE AREA WITH TOPICAL SILVADENE CREAM 3-4 TIMES PER DAY UNTIL THE SKIN SITE HEALED. THE PATIENT STATED THAT SCARRING PERSISTED, AND THE SKIN TOOK LONGER TO HEAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395142 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 5274353 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S