BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMARK® PROFESSIONAL Q FOR EVIVA® STANDARD

    MDR report key: 21941177 · Received May 1, 2025

    Report

    Report Number
    21941177
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    December 13, 2024
    Report Date
    April 24, 2025
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIOPSY CLIP DID NOT DEPLOY. (TWO SIMILAR EVENTS HAVE BEEN SUBMITTED FOR THIS TYPE OF DEVICE. THEY ARE SEPARATE EVENTS. THE DEVICE FAILURE WAS THE SAME FOR BOTH EVENTS.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208640 TUMARK® PROFESSIONAL Q FOR EVIVA® STANDARD MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-E13-S-Q-02 53143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown