BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 14881702 · Received June 30, 2022

    Report

    Report Number
    1000135560-2022-00015
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    January 21, 2022
    Report Date
    June 30, 2022
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE SPECIFIC MODEL OF MICROTIP DEVICE USED IN THE PROCEDURE WAS NOT REPORTED. THE TX2 MICROTIP WAS ENTERED ON THIS REPORT BECAUSE IT IS USED MORE OFTEN THAN THE OTHER MODELS OF MICROTIPS. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED. NOTE: THE PATIENT REPORTED A RANGE OF TIME FOR THE DATE OF THE PROCEDURE. THE MIDPOINT OF THIS RANGE WAS USED TO APPROXIMATE THE PROCEDURE DATE.

    Description of Event or Problem · 0

    A PATIENT REPORTED DISTRESSING PAIN FOLLOWING A PROCEDURE WITH A TENEX HEALTH DEVICE FOR PLANTAR FASCIITIS. THE PAIN STARTED SOON AFTER THE PROCEDURE AND INTENSIFIED AFTER RETURN TO WALKING. THE PLANTAR FASCIA PAIN RESOLVED AFTER THE PROCEDURE AND THE CURRENT PAIN IS APPARENTLY A DIFFERENT CONDITION. THE PATIENT'S MRI IMAGES WERE REVIEWED BY CLINICIANS. A STRESS REACTION, OR BONY EDEMA, IN THE HEEL WAS DIAGNOSED. CURRENTLY, THE PATIENT REPORTS SOME IMPROVEMENT IN HER CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280654 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other