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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	06/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event occurred in june 2023 involving burns to a patient's abdomen during a trusculpt treatment.An investigation was initiated at that time in collaboration with the treating clinic.The burns were reported by the clinic to be approximately 80-95% healed during follow-up and based on clinical assessment and available information at the time, the incident was not deemed to meet fda reportability criteria.The device was not returned or evaluated, as there was no indication of a malfunction or failure.The root cause of the incident was determined to be use error.Updated information: in may 2025, the clinic provided a follow-up photo of the treated area, which showed evidence of scar formation at the sites of the original burns.No new or ongoing adverse events have been reported by the clinic since the initial incident in (b)(6) 2023.Conclusion: the event has been reassessed in light of the updated clinical information, and this report is being submitted in accordance with fda requirements.The device functioned as intended, and no device-related malfunction contributed to the outcome.The root cause remains attributed to use error.

• 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: 22181031
• Report Number: 2954354-2025-00005
• Device Sequence Number: 8570448
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711230518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 05/31/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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: Disability
• Patient Sex: Female
• Patient Race: White