BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2133726 · Received June 17, 2011

    Report

    Report Number
    3004753838-2011-00184
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 19, 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 UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    PT'S PARENTS CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT AN ALLERGIC REACTION TO ADHESIVE THAT HAS NOT HEALED SINCE PT LAST WORE HIS SENSOR OVER A MONTH AGO. IT HAS BEEN VERIFIED THAT THE PT IS NOT USING ANY ALTERNATIVE PRODUCT UNDER THE SENSOR THAT COULD HAVE CAUSED THE ALLERGIC REACTION. PARENTS HAVE TAKEN PT TO SEE A DOCTOR WHO ADVISED THEM TO USE HYDROCORTISONE ON THE AFFECTED AREA. PT HAS NOT WORN HIS SENSOR YET SINCE PARENTS ARE WAITING FOR AREA TO HEAL BEFORE THEY USE SENSOR AGAIN.

    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 4 YR Other