BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP

    MDR report key: 9100496 · Received September 20, 2019

    Report

    Report Number
    1000135560-2019-00034
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    September 20, 2019
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR IF THE TENDON INJURY WAS RELATED TO THE ULCER TREATMENT ON THE BOTTOM OF THE FOOT. THE PATIENT PRESENTED WITH THE ISSUE 4-6 WEEKS AFTER TREATMENT. THE PHYSICIAN NOTED THAT THE TENDON QUALITY MAY HAVE BEEN COMPROMISED IN THE DISEASED FOOT. THE PHYSICIAN ALSO NOTED THAT HE MAY HAVE INADVERTENTLY CONTACTED THE TENDON WITH THE DEVICE DURING TREATMENT.

    Description of Event or Problem · 1

    A PATIENT PRESENTED WITH A STRAIGHT TOE AND FHL TENDON DAMAGE IN THE OPERATIVE FOOT 4-6 WEEKS AFTER A PROCEDURE WITH THE TENEX HEALTH TX SYSTEM. THE PROCEDURE WAS TO TREAT A DIABETIC FOOT ULCER AND PARTIALLY DEBRIDE THE SESAMOIDS. NO ISSUES WERE NOTED DURING THE PROCEDURE. THE ULCER HEALED IN 2 WEEKS. IT IS UNCLEAR IF THE TENDON INJURY WAS RELATED TO TREATMENT WITH THE TENEX HEALTH TX SYSTEM OR A PRE-EXISTING ISSUE WITH THE QUALITY OF THE TENDON IN THE DISEASED FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892317 TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other