BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK® VISION FOR EVIVA® STANDARD

    MDR report key: 23865831 · Received December 22, 2025

    Report

    Report Number
    3030927217-2025-00001
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195611222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. 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. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN VACUUM ASSISTED EXCISION OF A B3 LESION ON (B)(6) 2025, THE LESION CONTAINED A TUMARK ¨VISION¨BREAST MARKER. THE VACUUM ASSISTED EXCISION WAS PERFORMED USING A 7G BD ENCORE DEVICE. THE FACILITY REPORTED THAT THE MARKER WAS DAMAGED DURING THE PROCEDURE AND SEVERAL SMALL FRAGMENTS WERE LODGED WITHIN THE SURROUNDING BREAST TISSUE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328483 TUMARK® VISION FOR EVIVA® STANDARD MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-E13-S-VISION 04250195611222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other