BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK

    MDR report key: 14692766 · Received June 15, 2022

    Report

    Report Number
    1000408433-2022-00001
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    December 21, 2021
    Report Date
    May 10, 2022
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT IS SHOWING SYMPTONS OF A POSSIBLE ALLERGIC REACTION/REJECTION FROM THE BODY TO THE CLIPMARKER. THE PATIENT HAS TWO CLIPMARKERS FROM DIFFERENT MANUFACTURES IMPLANTED. THE Q-SHAPE CLIPMARKER FROM SOMATEX DESPITE MULTIPLE ATTEMPTS THE CUSTOMER DID NO FORWARD MORE INFORMATION. THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT ITSELF TO THE HOSPITAL AND FORWARDED FROM THE HOSPITAL TO THE DISTRIBUTOR/IMPORTER: - PATIENT HAD CLIP MARKERS PLACED IN DECEMBER 2021 AND FEELS SHE HAD DAILY ISSUES SINCE THE PROCEDURE PATIENT STATES HER BREAST TUMED BLACK AND ACHED ALMOST TWO MONTHS. THE ACHING PAIN THEN TURNED INTO OCCASIONAL SHARP AND STABBING PAINS STILL PERSIST TODAY. SHE BELIEVES SHE IS HAVING A REACTION TO CLIPS THAT WERE PLACED IN HER BREAST. PATIENT BELIEVES THERE WAS NO DISCUSSION THAT MAY CAUSE LONG TERM PAIN AND DISCOMFORT. PATIENT WOULD LIKE THE CLIPS REMOVED. PATIENT NOW HAS A RASH ON HER NECK THAT SHE BELIEVES IS RELATED TO HER CLIP PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813551 TUMARK TUMARK NEU SOMATEX MEDICAL TECHNOLOGIES GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R