MAUDE Adverse Event Report: CUTERA, INC. TRUSCULPT ID; MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Treatment date: (b)(6) 2024.Date patient reported adverse event to clinic: (b)(6) 2024.Date initial burn reported to cutera: (b)(6) 2025.Date clinic provided clinical information about the burn:(b)(6) 2025.Event description: a patient underwent treatment using the trusculpt 16 cm2 handpiece applied to the submental area and jawline.Following the procedure, the patient developed a thin, linear burn on the upper anterior neck, in the region of the hyoid bone, beneath the submental area.The patient did not report the burn to the clinic until approximately one month after treatment.The burn subsequently healed with a thin, linear scar.It is unknown what type of wound management, if any, was used during this period.Proper post-treatment care is essential to minimizing scar formation and achieving optimal cosmetic outcomes.Potential cause of the burn: user error.The trusculpt device uses radiofrequency (rf) energy to heat subcutaneous tissue.When the handpiece is applied over hard structures like the hyoid bone, there is an increased risk of thermal injury.Unlike areas with more soft tissue, bones do not dissipate heat as effectively, causing heat to concentrate in the thin layer of overlying skin.This can lead to localized burns.The location of the burn suggests that while treating the submental area, the device operator may have inadvertently placed the bottom edge of the handpiece against the hyoid bone, leading to excessive heat buildup and subsequent injury.Conclusion: no device malfunction has been identified, and the system has been in use since august 2024 without additional reported adverse events.
Additional Manufacturer Narrative
The trusculpt instructions for use were reviewed with the device operator, including the importance of avoiding direct contact with bony structures, such as the hyoid bone.

• Brand Name: TRUSCULPT ID
• Common Device Name: MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005
• MDR Report Key: 21615616
• Report Number: 2954354-2025-00001
• Device Sequence Number: 6668850
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711201219
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K221407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American