BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23752038 · Received December 8, 2025

    Report

    Report Number
    3009862700-2025-02105
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    March 3, 2025
    Report Date
    January 16, 2026
    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

    H1 TYPE OF REPORTABLE EVENT CORRECTED TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE SENSOR IS INSERTED BY MAKING A SMALL INCISION AND PLACING IT UNDER SKIN, AND POTENTIAL FOR DEVELOPING SKIN IRRITATION/INFLAMMATION/INFECTION AT THE INSERTION SITE IS A KNOWN ANTICIPATED ADVERSE EVENT. THE USER REPORTED EXPERIENCING ITCHING CAUSED BY THE WHITE ADHESIVE PATCHES. ACCORDING TO THE USER, THE SYMPTOMS FIRST APPEARED ON (B)(6) 2025. THE ADHESIVE PATCHES WERE CONFIRMED TO BE WITHIN THEIR EXPIRATION DATE (08-20-2027). BANDAGES OR TEGADERM WERE NOT BEING USED AT THE TIME THE SYMPTOMS OCCURRED. THE USER REPORTED APPLYING LOTIONS OR CREAMS TO THE AREA AND NOTED A HISTORY OF SENSITIVE SKIN. THE USER'S HCP IS AWARE OF THE EVENT AND PRESCRIBED A MEDICATED CREAM. PER DMS, THE USER IS CURRENTLY USING THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED EXPERIENCING ITCHING CAUSED BY THE WHITE ADHESIVE PATCHES. ACCORDING TO THE USER, THE SYMPTOMS FIRST APPEARED ON (B)(6) 2025. THE ADHESIVE PATCHES WERE CONFIRMED TO BE WITHIN THEIR EXPIRATION DATE (08-20-2027). BANDAGES OR TEGADERM WERE NOT BEING USED AT THE TIME THE SYMPTOMS OCCURRED. THE USER REPORTED APPLYING LOTIONS OR CREAMS TO THE AREA AND NOTED A HISTORY OF SENSITIVE SKIN. THE USER'S HCP IS AWARE OF THE EVENT AND PRESCRIBED A MEDICATED CREAM. PER DMS, THE USER IS CURRENTLY USING THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755448 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E347S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown