BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22121296 · Received June 1, 2025

    Report

    Report Number
    3009862700-2025-00757
    Event Type
    Injury
    Date Received
    June 1, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 1, 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

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS REVEALED THAT THE SENSOR LOT MET ALL REQUIREMENTS INCLUDING STERILIZATION REQUIREMENTS FOR RELEASE. THE SENSOR IS INSERTED BY MAKING A SMALL INCISION AND PLACING IT UNDER SKIN AND POTENTIAL FOR DEVELOPING SKIN IRRITATION/SWELLING/PAIN/ INFLAMMATION/INFECTION AROUND THE INSERTION SITE IS A KNOWN ANTICIPATED ADVERSE EVENT. IN ADDITION TO THIS, THE ADHESIVE PATCHES (CLEAR AND/OR WHITE) CAN CAUSE SKIN ALLERGIC REACTION OR SKIN IRRITATION, WHICH IS ALSO A KNOWN ANTICIPATED ADVERSE EFFECT. THE USER REPORTED SKIN IRRITATION AND REDNESS CAUSED BY THE CLEAR ADHESIVE PATCHES. ACCORDING TO THE USER, THE FIRST TIME THE SYMPTOMS APPEARED WAS ON (B)(6) 2025 AFTER CHARGING THE TRANSMITTER. THE USER'S HCP WAS AWARE OF THE EVENT AND PRESCRIBED FLONASE NASAL SPRAY BECAUSE IT HAS A STEROID.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED SKIN IRRITATION AND REDNESS CAUSED BY THE CLEAR ADHESIVE PATCHES. ACCORDING TO THE USER, THE FIRST TIME THE SYMPTOMS APPEARED WAS ON (B)(6) 2025 AFTER CHARGING THE TRANSMITTER. THE USER'S HCP WAS AWARE OF THE EVENT AND PRESCRIBED FLONASE NASAL SPRAY BECAUSE IT HAS A STEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643587 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 03F056S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male