BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2243532 · Received September 2, 2011

    Report

    Report Number
    3004753838-2011-00263
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 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 CONTACTED DEXOM TECHNICAL SUPPORT ON (B)(6) 2011, TO REPORT THAT SHE HAS BEEN EXPERIENCING IRRITATED AND PEELING SKIN FROM THE ADHESIVE ON THE SENSOR PATCH. PT CONSULTED WITH HER ENDOCRINOLOGIST WHO RECOMMENDED A HYDROCORTISONE CREAM TO USE PRIOR TO SENSOR WEAR BUT PT CLAIMS THAT THE CREAM USAGE INHIBITS THE SENSOR PATCH FROM ADHERING PROPERLY ON SKIN. AT THE TIME OF HER CALL TO DEXOM TECHNICAL SUPPORT, PT REPORTS WEARING A NEW SENSOR THAT SHE INTENDS TO REMOVE SOON DUE TO SKIN STARTING TO SWELL.

    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 34 YR Other