BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3864652 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03017
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 WAS HAVING ISSUES WITH THE SENSORS. CALLER STATED THAT AT THE TIME THE CUSTOMER REMOVED THE SECOND SENOR NOTICED THAT THE NEEDLE STAYED IN HER STOMACH AT THE INSERTION SITE. CALLER ALSO STATED THAT THE CUSTOMER WAS NOT ABLE TO REMOVE THE SENSOR NEEDLE FROM HER SITE. ADVISED TO ATTEMPT TO REMOVED THE CANNULA, OR SEEK MEDICAL ATTENTION TO REMOVED IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340783 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention