BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 14189768 · Received April 22, 2022

    Report

    Report Number
    3009862700-2022-00067
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 21, 2022
    Report Date
    March 22, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS. THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER THE REMOVAL STATUS OF THE SENSOR COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. D4. ADDITIONAL DEVICE INFORMATION UPDATED. D6A. IMPLANTED DATE UPDATED TO (B)(6) 2021. H4. DEVICE MANUFACTURER DATE UPDATED TO 14 APRIL 2021.

    Description of Event or Problem · 0

    ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR AFTER TWO ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982343 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP08306 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown