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	Full thickness (Third Degree) Burn (2696)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a trusculpt procedure targeting the lower abdomen.Following treatment, the patient developed two localized burn injuries on the right and left lower abdomen in areas corresponding to curve skin surfaces.One burn measured approximately 1.0 cm x 1.5 cm, and the other measured 1.0 cm x 4.0 cm.The treating clinician prescribed silvadene (silver sulfadiazine) topical ointment, oral antibiotics (bactrim), and gauze dressings for wound care.The patient reported a pain level of 2 out of 10 during the procedure.The burns were not reported to the clinic until three weeks post-treatment.According to the device operator, no unusual skin reaction was observed during or immediately following the procedure.A field service evaluation of the trusculpt system was conducted and confirmed that the device meets all performance specifications.The root cause has not been definitively identified.However, two potential contributing factors have been identified: 1) handpiece spacing relative to patient bmi: the burns were located in areas where the handpieces may have been placed too close together.The trusculpt instructions for use (ifu) include specific guidance regarding handpiece separation based on patient bmi.The patient's bmi was not documented and may have not been adequately considered during handpiece placement.2) treatment over curved anatomy: the injuries occurred over a curved region of the lower abdomen, which may have resulted in incomplete contact between the handpieces and the underlying skin, potentially affecting thermal distribution.The trusculpt ifu includes specific guidance regarding ensuring that the handpieces are in full contact with the underlying skin throughout treatment.An onsite retraining session has been scheduled for the clinic to review proper handpiece placement, treatment technique, and adherence to ifu guidelines.Burns are identified in the trusculpt ifu as a known potential adverse effect.

• 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 ; 4156575500
• MDR Report Key: 23297491
• Report Number: 2954354-2025-00007
• Device Sequence Number: 18637041
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711180914
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White