BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 14429995 · Received May 18, 2022

    Report

    Report Number
    3009862700-2022-00081
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    February 23, 2022
    Report Date
    April 18, 2022
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26 APRIL 2022, SENSEONICS WAS MADE AWARE THAT THE SENSOR WAS SUCCESSFULLY REMOVED ON THE SECOND ATTEMPT NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    ON 18 APRIL 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FROM THE USERS ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501888 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP08507 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female