BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 20540682 · Received October 26, 2024

    Report

    Report Number
    3009862700-2024-01010
    Event Type
    Injury
    Date Received
    October 26, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 21, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    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

    D2B.PRODUCT CODE CORRECTED TO SBA.

    Additional Manufacturer Narrative · 0

    B4.DATE OF THIS REPORT 21 JANUARY 2025. G3.DATE RECEIVED BY THE MANUFACTURER? 21 JANUARY 2025. H6.HEALTH EFFECT - IMPACT CODE (F) CORRECTED TO 4641. H6. INVESTIGATION CONCLUSIONS CORRECTED TO 4311.

    Additional Manufacturer Narrative · 0

    USER REPORTED AN EVENT WHERE THE USER WENT TO URGENT CARE DUE TO BLEEDING AT REMOVAL SITE DUE TO A BLOOD VESSEL GOT NICKED. URGENT CARE WAS ABLE TO ASSIST THE USER AND PROVIDED STITCHES.THE ISSUE WAS RESOLVED AND USER WAS ADVISED TO CONTACT HCP FOR ANY MEDICAL ASSISTANCE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER VISITED THE URGENT CARE DUE TO BLEEDING AT THE REMOVAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796154 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM SBA SENSEONICS INC. 103606-600 02E264S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Hospitalization