BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2121384 · Received June 7, 2011

    Report

    Report Number
    3004753838-2011-00172
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 12, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE WAS EXPERIENCING A RECURRING RED RASH FROM THE SENSOR ADHESIVE. PATIENT STATED THAT THE RASH LASTS APPROXIMATELY ONE WEEK AFTER SENSOR REMOVAL WITH NO OOZING OR FLUID AT THE SITE. PATIENT CONSULTED PHYSICIAN AND WAS GIVEN AN OINTMENT TO APPLY TO THE AFFECTED AREA. PATIENT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other