BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4222212 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-35994
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 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

    IT WAS REPORTED THAT THE CUSTOMER INSERTED A SENSOR THIS MORNING AND IT BEGAN TO BLEED SLOWLY AT FIRST. THEN, IT REALLY BLED AND CUSTOMER NOW HAS A HEMATOMA ON HIS SKIN THAT IS THE SIZE OF A GOLF BALL. CUSTOMER REMOVED THE SENSOR FROM HIS BODY. CUSTOMER DOES TAKE BLOOD THINNERS. CUSTOMER WAS ADVISED TO GET THE HEMATOMA CHECKED OUT. A REPLACEMENT SENSOR WILL BE SENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. CUSTOMER STATED THAT THE SITE WAS NOT ACTIVELY BLEEDING. CUSTOMER STATED THAT THE BLOOD WAS NOT VISIBLE ON THE SENSOR CONNECTOR. CUSTOMER STATED THAT THE SENSOR WAS NOT FULLY INSERTED. CUSTOMER STATED THAT THE SITE WAS NOT COMFORTABLE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703075 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G034U

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR