BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK® PROFESSIONAL X FOR BREVERA® STANDARD

    MDR report key: 21009610 · Received December 23, 2024

    Report

    Report Number
    1000408433-2024-00007
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    February 15, 2024
    Report Date
    December 23, 2024
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. H3: 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 ON (B)(6) 2024 DURING A BREVERA PROCEDURE, A TUMARK PROFESSIONAL MARKER WAS DEPLOYED. PATIENT REPORTED THAT IT BLED CONSIDERABLY AFTER THE PROCEDURE WAND THAT THE MARKER HAD MIGRATED 2.5 CM. LATER PATIENT REPORTED SHE KEPT BLEEDING AND THAT PAIN STARTED WITHIN DAYS AND THE INCISION BEGAN TO ITCH INTENSILY. PATIENT REPORTED THAT AN MRI SCAN WAS SCHEDULED AND THAT THE CANCER WAS UNABLE TO BE FOUND AT THE TIME DUE TO MULTIPLE FACTORS SUCH AS DENSE BREASTS, LACK OF VISIBILITY AND THE MIGRATION OF THE MARKER. DUE TO THIS THE PROVIDER USED 2 ADDITIONAL MARKERS A SECURMARK FOR EVIVA, TOPHAT AND MINICORK TO MARK THE BIOPSY SITES. THE PATIENT REPORTED THAT THE SECOND MARKER IMPLANTATION WAS EXTREMELY PAINFULL AND THAT PATHOLOGY CAME BACK WHICH THE PROVIDED RECOMMENDED A DIGITAL MOTION X-RAY WITH IMPLANTS TO AVOID DISFIGUREMENT. DURING THAT PERIOD THE MARKERS SEEMED TO IRRITATE AND CHEST PAIN WAS REPORTED. A 2ND MEDICAL OPINION WAS REQUESTED WHICH RESULTED IN A LUMPECTOMY ON AN UNKNOWN DATE WITH A ELUENT SMARTCLIP PLACED ON THE DAY PRIOR. DURING THE LUMPECTOMY THE MARKER FELL UPON INCISION DUE TO THE SUPERFICIAL POSITION IN THE SUPERIOR ANTERIOR MARGIN. PER THE RECORDS IT WAS SUTURED BACK IN. IT IS UNCLEAR WHICH MARKER THE PATIENT WAS REFERRING TO, ADDITIONAL FOLLOW UP FOR INFORMATION WERE NOT REPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965934 TUMARK® PROFESSIONAL X FOR BREVERA® STANDARD MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-BREV-S-X 52605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other