BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 7957221 · Received October 11, 2018

    Report

    Report Number
    1000135560-2018-00052
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    August 2, 2018
    Report Date
    October 11, 2018
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIVE DAYS AFTER A PROCEDURE WITH THE TENEX HEALTH TX SYSTEM, A PATIENT DEVELOPED PAIN AND HEMATOMAS IN HER FEET. THE HEMATOMAS WERE TREATED WITH CORTISONE SHOTS, DRAINAGE, HEAT TREATMENT AND DRESSING. THE HEALTH CARE PROVIDER SUSPECTS THE ISSUE IS NOT RELATED TO THE TREATMENT WITH THE TENEX HEALTH TX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798705 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other