BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK PROFESSIONAL

    MDR report key: 16371889 · Received February 14, 2023

    Report

    Report Number
    1000408433-2023-00001
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 14, 2023
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195600813
    PMA / PMN Number
    K201863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. 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 AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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 ON (B)(6) 2023, A PATIENT RECEIVED AFTER A BREAST BIOPSY A TUMARK MARKER U SHAPED AND 2 ADDITIONAL MARKERS FROM A DIFFERENT COMPANY (2 THIRD PARTY COMPANY CLIPMARKERS). ADDITIONALLY, 2 DEVICES FROM THIRD PARTY COMPANIES (NEEDLES) AND BANDAGES WERE USED ON THE PATIENT AS WELL AS LOCAL DOSE OF ANESTHETICS. AFTER THE PROCEDURE THE PATIENT DEVELOPED A GIANT URTICARIAL REACTION TO THE CHEST, ARM GROINS AND NECK FOR WHICH SHE RETURNED TO THE EMERGENCY ROOM. DUE TO THE PATIENT PERSISTING WITH AN ALLERGIC REACTION, ALL THE MARKERS WERE REMOVED 3 DAYS AFTER IMPLANTATION, THE PATIENT RECEIVED A HIGH DOSE OF ANTIHISTAMINES AND CORTICOSTEROIDS. A FEW DAYS AFTER THE REMOVAL AND DUE TO THE TREATMENT, THE PATIENT WAS DOING MUCH BETTER. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672514 TUMARK PROFESSIONAL TUMARK PROFESSIONAL NEU SOMATEX MEDICAL TECHNOLOGIES GMBH 271560 52090 04250195600813

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R