BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2101479 · Received May 2, 2011

    Report

    Report Number
    3004753838-2011-00122
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 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 MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED IRRITATION (RED, RAISED RASH AND BLISTERING) FROM THE SENSOR ADHESIVE PATCH ON THE LAST FOUR SENSORS. PT'S PARENTS CONSULTED WITH PT'S PHYSICIAN, WHO ADVISED THE USE OF ORAL BENADRYL AND TOPICAL CORTISONE, WHICH CLEARED THE RASH A FEW DAYS AFTER SENSOR REMOVAL. PHYSICIAN DID NOT RECOMMEND DISCONTINUING USE OF SENSORS. PT'S MOTHER STATED THAT PT DID NOT EXPERIENCE ANY PAIN OR DISCOMFORT AT THE SENSOR INSERTION SITE, ONLY UNDER THE ADHESIVE. PT ALSO DID NOT HAVE SYMPTOMS OF INFECTION OR FLUID EXUDING FROM THE SITE. PT HAD A RASH AT THE TIME OF HIS MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 4 OF 4 FOR THE COMPLAINT. SEE MDRS #3004753838-2011-00119, -00120, AND -00121 FOR REPORTS 1, 2, AND 3 OF 4, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5012427

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other