BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT ID

    MDR report key: 14628448 · Received June 7, 2022

    Report

    Report Number
    2954354-2022-00003
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 7, 2022
    Manufacturer
    CUTERA, INC.
    Product Code
    PBX
    UDI-DI
    00816722021427
    PMA / PMN Number
    K180709
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED THAT ABOUT 1 MIN INTO A LOWER ABDOMINAL FAT REDUCTION TREATMENT WITH THE TRUSCULPT ID DEVICE DELIVERED 5 DAYS PRIOR (B)(6) 2022) TO A HIGH BMI PATIENT, THE DEVICE STOPPED DELIVERING RF ENERGY AND DISPLAYED TWO ERROR CODES. THE CUSTOMER EXCHANGED THE CONSOLE PORTS TO WHICH HANDSFREE-HANDPIECES 1 AND 2 WERE CONNECTED TO FROM PORTS 1 AND 2 TO PORTS 2 AND 1, RESPECTIVELY, AND RESUMED THE TREATMENT. AT THE END OF THE 15 MIN TREATMENT, WHEN ALL 6 HANDPIECES IN USE WERE BEING REMOVED, THE CUSTOMER NOTICED THE PATIENT HAD A 5 CM X 1.5 CM LINEAR BLISTER UNDER THE RIGHT EDGE OF HANDPIECE 1 AND TWO SMALLER CIRCULAR BLISTERS CENTERED UNDER HANDPIECE 2. THE CUSTOMER GAVE THE PATIENT TOPICAL ANTIBIOTIC OINTMENT TO USES AS NEEDED TO KEEP THE BURNS MOIST DURING HEALING. WHEN THE PATIENT RETURNED TO THE CLINIC FOR A FOLLOW-UP VISIT ON (B)(6) 2022, THE 5 CM X 1.5 CM BLISTER WAS PARTIALLY UNROOFED IN TWO LOCATIONS AND ALL BLISTERS APPEARED TO BE BECOMING INFECTED. THE CUSTOMER REFERRED THE PATIENT TO A DERMATOLOGIST WHO PRESCRIBED 500 MG KEFLEX BID TO TREAT THE INFECTION, AND SUBSEQUENTLY THE PATIENT VISITED AN ER WHERE BACTRIM WAS ADDED. SINCE MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE INFECTION WHICH DEVELOPED IN PARTIAL-THICKNESS BURNS, THE EVENT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197432 TRUSCULPT ID ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES PBX CUTERA, INC. TRUSCULPT ID 00816722021427

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other