BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMARK PROFESSIONAL X FOR EVIVA STANDARD

    MDR report key: 25242335 · Received May 21, 2026

    Report

    Report Number
    3030927217-2026-00003
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195612069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2026, USING A TUMARK BIOPSY SITE MARKER, THE "X MARKER WAS DEPLOYED, STEREO PICTURE WAS TAKEN AND MARKER WAS SEEN. HELD PRESSURE FOR 10 MINUTES AND THEN TOOK [THE] PATIENT TO [THE] MAMMO ROOM FOR POST PICTURES. MARKER WAS NOT SEEN ON CC OR MLO PICTURES." ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER IN WHICH THE CUSTOMER DENIES THE OBSERVATION OF HEAVY BLEEDING WHEREAS THE MARKER MAY HAVE BEEN INADVERTENTLY FLUSHED OUT AND REPORTS THAT HOLDING PRESSURE AT THE SITE FOR 10 MINUTES "IS OUR AVERAGE PRESSURE TIME." IT IS REPORTED THAT THE CANNULA, 4X4 GAUZE AND SURROUNDING AREAS WERE SEARCHED FOR THE MARKER; HOWEVER, IT COULD NOT BE LOCATED. NO PATIENT HARM OR ADDITIONAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460078 TUMARK PROFESSIONAL X FOR EVIVA STANDARD MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-E13-S-X-02 54103 04250195612069

    Patients

    Seq Age Sex Outcome Treatment
    1