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	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinical that owns the trusculpt system initially contacted cutera to request suggestions on wound management options to help minimize the potential risk of scarring.Cutera did not provide medical advice for wound care management or scar reduction.The treatment was performed approximately two weeks prior to the report to cutera.A 48 year old female patient with fitzpatrick skin type v underwent a hands-free trusculpt procedure using six handpieces to the lower abdomen, mid-abdomen, and bilateral flanks.Two return pads were placed on the upper back.The patient did not report pain or discomfort during the procedure, and the skin appeared normal upon removal of the return pads.The operator noted a moderate amount of sweating during treatment.The following day, the patient developed a blister approximately the "size of a quarter" at the lower corner of the return pad electrode.The clinic expressed concern about potential keloid formation.The patient was advised to apply aquaphor, keep the site covered, and avoid sun exposure; healing was reported to be "slow".There were no device malfunctions, error codes, or performance complaints reported.Based on available information, cutera cannot definitively determine the root cause.The event may be related to partial lifting of the return pad, which is a known risk factor for localized burns, potentially exacerbated by sweating or uneven pad adhesion.Cutera will monitor for similar events.

• 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: 23069670
• Report Number: 2954354-2025-00006
• Device Sequence Number: 4645064
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711190228
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2019
• 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: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American