BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCALIZER

    MDR report key: 23656494 · Received November 26, 2025

    Report

    Report Number
    23656494
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 10, 2025
    Manufacturer
    HEALTH BEACONS, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH RIGHT BREAST CANCER UNDERGOING RF [RADIOFREQUENCY] TAG LOCALIZED PARTIAL MASTECTOMY AND SENTINEL NODE BIOPSY. RF TAG PLACED PRIOR TO SURGERY AND TAG SIGNAL CONFIRMED PRIOR TO INCISION. DURING PROCEDURE TAG COULD NOT BE LOCALIZED USING DETECTOR UNIT. SIGNAL WAS DETECTED WITHOUT TAG NUMBER. INTERMITTENTLY THE TAG SIGNAL WITH TAG NUMBER WAS IDENTIFIED. WE ULTIMATELY VISUALIZED THE TAG, AND THE PROBE DID NOT IDENTIFY A SIGNAL WHILE DIRECTLY ON THE TAG. THIS RESULTED IN THE CREATION OF A LARGER LUMPECTOMY SPECIMEN INCLUDING AN ADDITIONAL SUPERIOR MARGIN. PATHOLOGY IS PENDING. THE TAG CONTINUES TO BE AN UNRELIABLE TECHNOLOGY FOR USE FOR LOCALIZATION OF NONPALPABLE LESIONS OF THE BREAST. MANUFACTURER RESPONSE FOR LOCALIZER, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136985 LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU HEALTH BEACONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female