BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXB TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 10405661 · Received August 13, 2020

    Report

    Report Number
    1000135560-2020-00038
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 18, 2020
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. FIELDS A1, A2, A4, A5, A6, B3, B4, E1, G4, G7, H1, H2 AND H10 UPDATED. ADDITIONAL INFORMATION ON THE PATIENT AND EVENT WAS PROVIDED. THE PATIENT WAS APPARENTLY STARTED ON ANTIBIOTICS EITHER THE DAY OF, OR THE DAY BEFORE, THE PROCEDURE. FOLLOWING ADMISSION TO THE HOSPITAL, THE PATIENT REQUIRED INCISION AND DRAINAGE OF THE SURGICAL SITE, IV ANTIBIOTICS AND RESECTION OF APPROXIMATE FOOT JOINT. THE PATIENT ALSO EXPERIENCED DELAYED CLOSURE OF THE INCISION.

    Description of Event or Problem · 1

    A USER REPORTED AN INFECTION IN THE WOUND AREA OF A DIABETIC FOOT ULCER IN A PATIENT TREATED WITH THE TENEX HEALTH TX SYSTEM. IT IS UNCLEAR IF PROPHYLACTIC ANTIBIOTICS WERE USED. A C-ARM (FLUOROSCOPIC IMAGER) WAS APPARENTLY USED DURING THE PROCEDURE, AND POSSIBLY NOT STERILE DRAPED. THE REPORTER FELT THAT BACTERIA WERE LIKELY PRESENT AT THE DFU WOUND BEFORE AND/OR AT TIME OF TREATMENT. TWO PORTALS WERE MADE AROUND THE WOUND FOR TREATMENT WITH THE TXB MICROTIP. THE TREATED AREAS WERE FLUSHED FOR APPROXIMATELY ONE MINUTE FOLLOWING TREATMENT. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR FURTHER CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869925 TXB TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 19119-02-202106

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other