BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP

    MDR report key: 10759983 · Received October 29, 2020

    Report

    Report Number
    1000135560-2020-00044
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    December 31, 2019
    Report Date
    October 29, 2020
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006093
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF A THERMAL BURN FOLLOWING A PROCEDURE WITH A TXB MICROTIP WAS DISCOVERED IN A WEBINAR PRESENTED BY A PHYSICIAN. THE PHYSICIAN REPORTED THAT THE INJURY OCCURRED IN A PROCEDURE PERFORMED BY A DIFFERENT PHYSICIAN. THE PHYSICIAN USED THE TXB MICROTIP TO TREAT A CHRONIC NONUNION TALAR SPUR. A THERMAL BURN AND OPENED BLISTER WERE EVIDENT ON DAY 2 AFTER THE PROCEDURE. SHARP DEBRIDEMENT WAS USED TO REMOVE NECROTIC TISSUE. THEN AQUACEL FOAM DRESSING WAS APPLIED TO THE BURN SITE. THE BURN PROCEEDED TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218976 TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 NI 00857156006093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other