BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK CONIC

    MDR report key: 20010360 · Received August 21, 2024

    Report

    Report Number
    1000408433-2024-00002
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 16, 2024
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    PMA / PMN Number
    K201863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. 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 THAT A PATIENT HAD RECEIVED A MARKER IN (B)(6) 2024 AND SINCE THE PATHOLOGY CAME BACK BENIGN THERE WERE NO PLANS TO REMOVE IT. BUT THE PATIENT HAS BEEN EXPERIENCING PAIN, INFLAMMATION AND SWELLING IN HER ARM AND AXILLA. PATIENT WENT TO THE EMERGENCY ROOM AND STATED THAT THE PHYSICIAN HAD TOLD HER THAT ¨ THE CAUSE WAS THE CLIP¨ AND NEEDED TO BE REMOVED AS SOON AS POSSIBLE. AS OF THE DATE OF THIS REPORT IT IS UNCLEAR IF THE DEVICE WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992886 TUMARK CONIC TUMARK CONIC NEU SOMATEX MEDICAL TECHNOLOGIES GMBH 351262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other