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

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event summary: cutera received a report of a burn sustained by a 68-year-old female client (initials (b)(6) skin type iv, bmi reported as "overweight") following a trusculpt hands-free radiofrequency (rf) treatment to the lower abdomen.Cutera was not present during the client assessment or treatment.Description of the injury: the burn was located on the right lower abdomen in an area with visible stretch marks and curved tissue.Review of the photographs shows a linear burn pattern with squared edges.This pattern may be consistent with partial lifting of the handpiece and/or decal during treatment.Lifting of the handpiece or decal can reduce skin contact and result in localized increases in rf energy.Excessive sweating during treatment was reported, which may have further reduced decal adhesion and consistent skin contact.Treatment setup considerations: handpiece spacing and the client's numeric bmi were not documented.As a result, cutera is unable to fully assess whether handpiece spacing was consistent with treatment guidelines.Device evaluation: a field service evaluation was performed on 2 december 2025 (case (b)(4) / work order (b)(4)).All handpieces were tested and found to meet cutera performance specifications.As a precaution, the return pad cable was replaced due to a reported connector issue.No device malfunction or performance abnormality was identified, and the return pad cable issue is not expected to have contributed to the reported burn.Assessment of possible contributing factors: based on the information available, a definitive root cause could not be determined.The following factors may have contributed to the event: *treatment of a curved area of the body, which can increase the risk of handpiece lift *presence of stretch marks, which can alter skin texture and make it difficult for decals to lie flat.*excessive sweating, which may reduce decal adhesion and consistent skin contact *unknown handpiece spacing relative to the client's bmi, which may increase the risk of burns at the edges of the handpieces if spacing is insufficient.Conclusion: the reported burn represents a known potential adverse effect of the trusculpt treatment, as described in the instructions for use.No evidence of device failure or malfunction was identified.

• 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: 23927252
• Report Number: 2954354-2025-00010
• Device Sequence Number: 21023716
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711210924
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White