BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT ID

    MDR report key: 19684674 · Received July 5, 2024

    Report

    Report Number
    2954354-2024-00011
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    June 5, 2024
    Report Date
    October 1, 2024
    Manufacturer
    CUTERA, INC.
    Product Code
    GEI
    UDI-DI
    00816722021427
    PMA / PMN Number
    223110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 16 CM2 HANDPIECE WAS USED TO TREAT THE SUBMENTUM AND NECK AREA. THE TRUSCULPT ID OPERATOR MANUAL INSTRUCTS THE DEVICE OPERATOR NOT TO TREAT "ON THE HEAD OR ON THE NECK (INCLUDING CAROTID SINUS OR OVER THE TRACHEA OR THYROID CARTILAGE)". THE PATIENT EXPERIENCED A SMALL, LINEAR, DEEP PARTIAL THICKNESS BURN ON THE SIDE OF THE NECK. THE WOUND MANAGEMENT IS BACITRACIN. THE DEVICE IS PENDING INSPECTION AND TESTING BY CUTERA SERVICE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON JULY 5, 2024. AS REPORTED INITIALLY, THE 16 CM2 HANDPIECE WAS USED TO TREAT THE SUBMENTUM AND NECK AREA. THE TRUSCULPT ID OPERATOR MANUAL INSTRUCTS THE DEVICE OPERATOR NOT TO TREAT "ON THE HEAD OR ON THE NECK (INCLUDING CAROTID SINUS OR OVER THE TRACHEA OR THYROID CARTILAGE)". THE PATIENT EXPERIENCED A SMALL, LINEAR, DEEP PARTIAL THICKNESS BURN ON THE SIDE OF THE NECK. THE WOUND MANAGEMENT WAS BACITRACIN. THE AREA HEALED WITH A VISIBLE LINEAR SCAR. AT THE TIME OF THE INITIAL EMDR, CUTERA WAS AWAITING RETURN OF THE HANDPIECE FOR INSPECTION AND TESTING. HOWEVER, THE CUSTOMER HAS CHOSEN NOT TO RETURN THE HANDPIECE AND HAS DECLINED A FIELD SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961995 TRUSCULPT ID MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT GEI CUTERA, INC. TRUSCULPT ID 00816722021427

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other