BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK VISION FOR EVIVA STANDARD

    MDR report key: 25057175 · Received May 1, 2026

    Report

    Report Number
    3030927217-2026-00002
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    September 16, 2025
    Report Date
    May 1, 2026
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195611222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DEVICE AT THE TIME OF THIS REPORT. 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

    HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT RECEIVED A TUMARK VISION FOR EVIVA STANDARD BREAST MARKER ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT THE PATIENT DEVELOPED A "SEVERE INFLAMMATORY REACTION," AND THE DEVICE WAS SURGICALLY REMOVED ON (B)(6) 2025. ADDITIONALLY, IT IS REPORTED THAT DIAGNOSIS OF THE EXCISED TISSUE CONFIRMED THE PRESENCE OF "FOREIGN BODY GRANULOMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63265 TUMARK VISION FOR EVIVA STANDARD MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-E13-S-VISION 190509009 04250195611222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other