BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX2 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 8846641 · Received July 31, 2019

    Report

    Report Number
    1000135560-2019-00023
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    May 1, 2017
    Report Date
    July 31, 2019
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AN ARTICLE PUBLISHED IN SCIENTIFIC LITERATURE REPORTED A SUPERFICIAL SKIN INFECTION THAT RESOLVED WITH ORAL ANTIBIOTICS IN ONE PATIENT. THE ARTICLE PRESENTED A RETROSPECTIVE REVIEW OF CHARTS DATED BETWEEN SEPTEMBER 2013 AND MAY 2017 FOR PATIENTS WHO HAD UNDERGONE PERCUTANEOUS ULTRASONIC TENOTOMY FOR INSERTIONAL ACHILLES TENDINOPATHY WITH THE TENEX HEALTH TX SYSTEM. NO ADDITIONAL DETAILS ON THE COMPLICATION WERE PROVIDED. NO OTHER COMPLICATIONS WERE NOTED. CHIMENTI RL, ET AL. PERCUTANEOUS ULTRASONIC TENOTOMY REDUCES INSERTIONAL ACHILLES TENDINOPATHY PAIN WITH HIGH PATIENT SATISFACTION AND A LOW COMPLICATION RATE. J ULTRASOUND MED 2018; 00:1-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641437 TX2 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other