BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 17715938 · Received September 8, 2023

    Report

    Report Number
    1000135560-2023-00035
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    May 1, 2023
    Report Date
    September 8, 2023
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A PATIENT REPORTED AN EDEMA DURING A PROCEDURE WITH THE TENEX HEALTH TX2 MICROTIP. HE FURTHER NOTED A RECESSION AND DISCOLORATION ON THE SKIN IN THE AREA OF TREATMENT FOLLOWING THE PROCEDURE. HE REPORTED THAT HIS TENDONITIS SYMPTOMS WERE WORSE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712930 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other