BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXB TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 10782043 · Received November 3, 2020

    Report

    Report Number
    1000135560-2020-00045
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    December 31, 2019
    Report Date
    November 3, 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

    A PHYSICIAN REPORTED BLEEDING AND AN INFECTION FOLLOWING A PROCEDURE WITH THE TX SYSTEM IN A WEBINAR PRESENTATION. THE COMPLICATION OCCURRED AROUND THE OPERATIVE SITE IN THE FOOT OF THE PATIENT. THERE WAS ALSO A REPORT OF RECURRENT CALCIFICATION IN THE TENDON ABOVE THE HEEL SIX MONTHS AFTER TREATMENT. THE PROCEDURE WAS PERFORMED BY A DIFFERENT PHYSICIAN THAN THE ONE WHO PRESENTED THE WEBINAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247087 TXB TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 NI 00857156006093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other