BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULOC

    MDR report key: 19795362 · Received July 22, 2024

    Report

    Report Number
    1000408433-2024-00001
    Event Type
    Injury
    Date Received
    July 22, 2024
    Report Date
    July 22, 2024
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    MIJ
    UDI-DI
    04250195600844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT 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. THE DEVICE HAS BEEN DISCARTED BY THE CUSTOMER, THUS IT WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A MARKING OF BREAST LESION USING A TULOC DEVICE, A PATIENT HAD TO BE OPERATED ON TWICE, DUE TO THE DEVICE DISLOCATED AND WAS BEING STUCK IN THE INCORRECT POSITION. BETWEEN THE 1ST AND 2ND PROCEDURE APPROXIMATELY 6 WEEKS TRANSPIRED. THE WIRE COULD NOT BE REMOVED FROM THE PATIENT IN QUESTION AS IT HAD SHORTENED AFTER BEING IN THE FIRST POSITION. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980024 TULOC TULOC MIJ SOMATEX MEDICAL TECHNOLOGIES GMBH 271661 53004 04250195600844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other