BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMARK VISION

    MDR report key: 24019746 · Received January 9, 2026

    Report

    Report Number
    3030927217-2026-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    October 22, 2025
    Report Date
    January 9, 2026
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195607836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER PLACED A TUMARK VISION BREAST MARKER INTO THE BREAST OF A PATIENT "WITHOUT PROBLEMS." IT IS FURTHER REPORTED THAT THE USER LATER NEEDED TO ACQUIRE EXTRA BIOPSIES FROM THE SAME AREA AND IT APPEARS THAT THE BIOPSY NEEDLE BROKE THE PREVIOUSLY PLACED TUMARK VISION MARKER. THE USER REPORTS THAT NO FURTHER BIOPSY PROCEDURES ARE REQUIRED FOR THIS PATIENT AND THE TUMARK VISION MARKER CAN REMAIN IN THE PATIENTS BREAST. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83665 TUMARK VISION MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH 271590 53331 04250195607836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown