BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12594195 · Received October 7, 2021

    Report

    Report Number
    3009862700-2021-00126
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    January 31, 2019
    Report Date
    September 7, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH CARE PROFESSIONAL REMOVED THE SENSOR WHICH WAS COMING OUT FROM THE WOUND ON (B)(6) 2021 AND SHARED THAT THERE WAS NO INFECTION, NO REDNESS, NO HEAT, NO INFLAMMATION, NO SENSOR FRAGMENT DETECTED IN THE LOCATION OF THE PRIOR REMOVAL, AND NO CLINICAL CONCERN. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    ON 07 SEPTEMBER 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER NOTICED THE CURRENT SENSOR WAS COMING OUT FROM THE WOUND, HE SAW THAT THIS OLD SCAR WAS INFECTED AS IT WAS RED, SWOLLEN AND HURTING. USER SHARED THAT THIS WAS FROM AN OLD REMOVAL PERFORMED BACK ON 2018 OR 2019, AND THAT HE BELIEVED THAT THE SENSOR HAD BROKEN UP AND HE MIGHT STILL HAVE A PIECE ON HIS ARM. HEALTH CARE PROFESSIONAL REMOVED THE SENSOR WHICH WAS COMING OUT FROM THE WOUND ON (B)(6) 2021 AND SHARED THAT THERE WAS NO INFECTION, NO REDNESS, NO HEAT, NO INFLAMMATION, NO SENSOR FRAGMENT DETECTED IN THE LOCATION OF THE PRIOR REMOVAL, AND NO CLINICAL CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492067 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08306 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other