BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUMARK® PROFESSIONAL Q FOR BREVERA® PETITE

    MDR report key: 20906894 · Received December 11, 2024

    Report

    Report Number
    1000408433-2024-00006
    Event Type
    Injury
    Date Received
    December 11, 2024
    Report Date
    December 11, 2024
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195611338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    HOLOGIC RECEIVED INFORMATION THROUGH A RETROSPECTIVE SURVEY RELATED TO PATIENT RECORDS. IT WAS DOCUMENTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024 A PATIENT EXPERIENCED INFLAMMATION THAT RESOLVED WITHOUT MEDICAL INTERVENTION. THE ISSUE WAS REPORTED AS HAPPENED 1 MONTH AFTER IMPLANTATION. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428425 TUMARK® PROFESSIONAL Q FOR BREVERA® PETITE MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK-BREV-P-Q 04250195611338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other