BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULOC

    MDR report key: 20407802 · Received October 9, 2024

    Report

    Report Number
    1000408433-2024-00003
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 9, 2024
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    MIJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, DURING A BREAST SURGERY THE TULOC WIRE CAME OUT OF TISSUE DURING THE SURGERY. THE PHYSICIAN REPORTED THAT HAD TO TAKE MORE TISSUE TO ENSURE THAT THE CANCER WAS REMOVED FROM THE BODY. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17334 TULOC TULOC MIJ SOMATEX MEDICAL TECHNOLOGIES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other