BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT ID

    MDR report key: 19803092 · Received July 23, 2024

    Report

    Report Number
    2954354-2024-00013
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 22, 2024
    Manufacturer
    CUTERA, INC.
    Product Code
    GEI
    UDI-DI
    00816722021427
    PMA / PMN Number
    K223110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT RECEIVED A 2 X 2 CM DEEP PARTIAL THICKNESS BURN BETWEEN TWO HANDPIECES PLACED ON THE LOWER ABDOMEN. THE BURN DEVELOPED INTO A BLISTER AND WAS TREATED WITH POLYSPORIN, VASELINE, AND MEDI-HONEY. THE PATIENT'S REPORTED BMI IS 33.8. THE TRUSCULPT ID INSTRUCTIONS FOR USE STATE THE FOLLOWING: CAUTION: HANDPIECES SHOULD BE SPACED BASED ON THE PATIENT'S BMI AND/OR UNDERLYING FAT THICKNESS IN THE TREATMENT AREA TO PREVENT ADVERSE EVENTS. FOR BMI 26-30 OR >1 CM FAT THICKNESS, PLACE HANDPIECES >1 CM APART. UP TO 2 HANDPIECES CAN BE USED ON LARGE OR SMALL DECALS, VERIFYING 1 CM OR MORE SEPARATION BETWEEN HANDPIECES." THE BURN RESULTED FROM INSUFFICIENT SEPARATION BETWEEN THE HANDPIECES PLACED ON THE LOWER ABDOMEN. SPECIFICALLY, THREE HANDPIECES WERE POSITIONED ON A SINGLE DECAL, LEADING TO INSUFFICIENT SPACE BETWEEN THE HANDPIECES. THE TRUSCULPT ID SYSTEM WAS EVALUATED BY CUTERA FIELD SERVICE AND MET PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440072 TRUSCULPT ID MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT GEI CUTERA, INC. TRUSCULPTID 00816722021427

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other