BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 3171143 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02459
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 EXPERIENCED EXTREME PAIN AFTER INSERTING THE SENSOR. IT WAS STATED THAT THE CUSTOMER HAD TO SEEK MEDICAL ATTENTION, AND WAS TOLD THAT THE SENSOR HAD PIERCED THE MUSCLE IN THE ABDOMEN, CAUSING THE SITE TO BLEED. IT WAS ALSO STATED THAT THE CUSTOMER WAS TAKING BLOOD THINNERS. ADVISED TO ALWAYS CHANGE THE SENSOR WHEN EXPERIENCING PAIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271005 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C B193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization