BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT ID

    MDR report key: 20186187 · Received September 10, 2024

    Report

    Report Number
    2954354-2024-00015
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    June 2, 2024
    Report Date
    October 23, 2024
    Manufacturer
    CUTERA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K223110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT SUSTAINED A DEEP PARTIAL THICKNESS BURN OF ~1.5 CM, WHICH RESULTED IN A VISIBLE DEPRESSED SCAR. THE INCIDENT OCCURRED DURING A DEVICE DEMONSTRATION FOR WHICH THE PATIENT VOLUNTEERED AS A MODEL. THE INCIDENT IS UNDER INVESTIGATION TO IDENTIFY THE DEVICE SERIAL NUMBER AND OPERATOR.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON AUGUST 30, 2024. AS INITIALLY REPORTED, THE PATIENT SUSTAINED A DEEP PARTIAL THICKNESS BURN OF ~1.5 CM, WHICH RESULTED IN A VISIBLE DEPRESSED SCAR. THE INCIDENT OCCURRED DURING A DEVICE DEMONSTRATION FOR WHICH THE PATIENT VOLUNTEERED AS A MODEL. AT THE TIME OF THE INITIAL EMDR, THE INCIDENT WAS UNDER INVESTIGATION TO IDENTIFY THE DEVICE SERIAL NUMBER AND OPERATOR. SINCE THAT TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE INITIAL REPORTER, SO WE ARE UNABLE TO CONCLUSIVELY IDENTIFY THE ROOT CAUSE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563968 TRUSCULPT ID MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT GEI CUTERA, INC. TRUSCULPTID

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other