BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX TX2 PROCEDURE PACK

    MDR report key: 23149167 · Received September 25, 2025

    Report

    Report Number
    MW5176628
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    September 22, 2025
    Report Date
    September 23, 2025
    Manufacturer
    TRICE MEDICAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRICE MEDICAL TX 2 PROCEDURE PACK (REFERENCE # 554-2003-001, LOT # 0922401, EXPIRATION 04/01/26) WAS USED FOR A PODIATRY PROCEDURE. WHEN THE SURGEON REMOVED THE TX 2 MICROTIP HANDPIECE FROM THE PATIENT, THE END OF THE TX2 MICROTIP HANDPIECE CAME APART IN PIECES. ALL PARTS WERE ACCOUNTED FOR, X-RAY CONFIRMED NO RETAINED PIECES OF HANDPIECE. (B)(6), REPRESENTATIVE FOR TENEX WAS PRESENT FOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303952 TENEX TX2 PROCEDURE PACK INSTRUMENT, ULTRASONIC SURGICAL LFL TRICE MEDICAL 554-2003-001 0922401

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention