BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK Q

    MDR report key: 10122071 · Received June 5, 2020

    Report

    Report Number
    1000408433-2020-00001
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 5, 2020
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195603081
    PMA / PMN Number
    K073095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UP TO TODAY, IT IS NOT PROVEN THAT THE CLIP MARKER LEADED TO THIS INCIDENT. THE PATIENT INITIALLY WENT TO THE CLINIC BECAUSE OF AN INFLAMMATION ON THE BREAST. AT THIS TIME, THE CLIP MARKER WAS NOT IMPLANTED AT ALL. ALSO, THE OTHER LATER DEVELOPED SYMPTOMS COULD BE CAUSED BY HER BREAST CANCER DISEASE. FURTHERMORE, A NICKEL ALLERGY IS NOT DIAGNOSED, YET. IN CASE THAT THE SYMPTOMS ARE CAUSED BY A NICKEL ALLERGY, THE PHYSICIAN WOULD HAVE HAD APPLIED THE CLIP MARKER, IGNORING THE CONTRAINDICATIONS OF THE PRODUCT. BEFORE IMPLANTING THE CLIP MARKER THE PATIENT WAS NOT ASKED, WHETHER SHE HAS ANY ALLERGIES TO NICKEL. IN THE INSTRUCTION FOR USE IT IS STATED THAT THE CLIP MARKER CONSISTS OF NICKEL-TITANIUM. THE SECTION "CONTRAINDICATIONS" CONTAINS, THAT "THE USE OF THE TUMARK® Q IS CONTRAINDICATED IN PATIENTS WHO SUFFER FROM A SEVERE NICKEL ALLERGY."

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION HAS BEEN SENT BY (B)(6) TO SOMATEX MEDICAL TECHNOLOGIES (B)(4): PATIENT (FEMALE, (B)(6)) CAME (B)(6) 2020 TO THE CLINIC FOR TUMORS ( ZAGREB) BECAUSE OF INFLAMMATION ON THE BREAST. AFTER EXAMINATION WITH ULTRASOUND AND MAMMOGRAPHY, PATIENT WAS RECOMMENDED BIOPSY. DURING BIOPSY, MARKATION WAS LEFT IN THE BREAST WITHOUT PATIENT KNOWLEDGE USING TUMARK Q. PATIENT WAS NOT ASKED IF SHE HAD ANY ALLERGIES TO NI (NITIOL). TUMARK Q, LENGTH 12 CM, DIAMETER 18G, REF 271500, LOT 18132 WAS USED ON THE PATIENT. (B)(6) 2020 PATIENT REPORTS TO THE SAME CLINIC TO PICK UP TEST RESULTS AND COMPLAINED TO THE DOCTOR ABOUT ITCHING AND STINGING FEELING IN THE BREAST. DOCTOR ASSURES HER THAT IT IS A NORMAL FEELING BECAUSE OF CARCINOM. AFTER SENDING HOME, PATIENT DOES NOT FEEL WELL AND TAKES ANALGETICS AND THAT AFTERNOON DUE TO UNBEARABLE PAIN AND STINGING REPORTS TO THE EMERGENCY UNIT IN CLINIC FOR TUMORS (ZAGREB) WHERE SHE WAS SENT AWAY. IN EMERGENCY UNIT IN ANOTHER HOSPITAL SHE IS TREATED WITH ANTIBIOTICS AND AGAIN SENT HOME. ON (B)(6) 2020 PATIENT IS EXAMINED WITH ULTRASOUND AND COLOR DOPPLER IN PRIVATE CLINIC. MARKATION AND Q TIP ARE DISPLACED AND DISINTEGRATED AND ON THE BREASTS ARE VISIBLE BRUISES. THERE IS ALSO A DANGER OF NI POISONING AND MIGRATION OF TUMARK MARKATION. PATIENT IS IN LIFE THREATENING SITUATION AND ENDURES GREAT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585753 TUMARK Q TUMARK Q NEU SOMATEX MEDICAL TECHNOLOGIES GMBH 271500 18132 04250195603081

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening