MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE CPT SYSTEM TIP; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TTNS3.00E4-900
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blister (4537)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a blister on the left side of the forehead a day after receiving a thermage cpt treatment of the face and neck.It was reported that the patient was sedated with nitrous oxide to complete the treatment.No secondary interventions were provided to the patient as a result of this event.The patient¿s current status and the possibility of any permanent damage or scarring remains unknown.The unused treatment tip was not inspected prior to starting or throughout the procedure.According to the reporter, during the treatment two error messages were received indicating that tuning was needed.The highest energy used was 3mj, using the stamping method.The user facility confirmed using solta cryogen and coupling fluid to complete the treatment; a gel application was applied per row.No other treatments (besides the one reported) were performed in the same area where symptoms were reported.The patient had no history of aesthetic treatments.No additional information is able to be received from the patient, as the clinic has been unable to contact them.No patient photos are available to be reviewed.The treatment tip was discarded by the user facility; therefore, it will not be returned for evaluation.
Additional Manufacturer Narrative
The datacard logs were returned for evaluation and it was determined that during the procedure a force too high when button pushed displayed 11 times, an underforce during radio frequency on error displayed 3 times, and a temperature limit exceeded also occurred 3 times.An error indicates a recoverable problem that requires operator intervention.If the error occurs during a radio frequency treatment, the radio frequency delivery will be stopped.A post-cooling step will then be completed prior to generating an ¿error tone¿ and display the event code and event message.After the error tone, the system will transition into an action required mode and it will display a text with further instructions for the operator on what action may be required in order to resolve the issue.Based on the evaluation of the data, the tuning event code that was confirmed, however, the handpiece and the system performed as expected.Based off the logs these events could have been technique related.If the system identifies a potential technique issue, the temperature monitor will catch this condition and display an error and place the system into a safe state.This condition presents no patient risk.Solta strongly discourages users from placing patients under local injections, tumescent anesthetic, or nerve block techniques to manage patient comfort during thermage procedures.The patient must be alert and provide required feedback during treatment.Patient feedback regarding their perception of heat or discomfort during the procedure is an essential input to guide the operator in determining safe and effective treatment levels.According to the thermage cpt system user manual, blisters are known possible side effects of thermage cpt treatment.The procedure produces heating in the upper layers of the skin, and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.The treatment tip was discarded and could not be obtained for an evaluation.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.At this time, no capa is necessary.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Common Device Name: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 22216591
• Report Number: 3011423170-2025-00281
• Device Sequence Number: 8748403
• Product Code: GEI
• UDI-Device Identifier: 00850608002445
• UDI-Public: 00850608002445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2025

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
• Device Model Number: TTNS3.00E4-900
• 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: 05/18/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown