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

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Burning Sensation (2146); Hyperpigmentation (4837)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced a burning sensation and had redness and hyperpigmentation on their left cheek following a thermage treatment.After the treatment was completed, it was observed the patient had white lines and discoloration on their left cheek.An ice pack and 1% hydrocortisone were applied to the affected area.A solta medical reviewer examined pictures of the patient injury.Two pictures of the patient's face on one side were provided.The pictures revealed a possible burn on the left cheek area.The patient¿s current status 18 days post-procedure is that they are improving, and permanent damage is not expected.The patient had no history of aesthetic treatments.Solta medical branded cryogen and 4/5 of a bottle of coupling fluid was used with the highest level of treatment at 4.0.The patient had received thermage treatment to their face and no system errors occurring during the procedure.The provider observed after 860 pulses were delivered that the treated area seemed to heat up quickly and more than normal redness had developed.This was the first time the treatment tip was used, and it was inspected prior to use, and again at 600 pulses, with no discrepancies found.
Additional Manufacturer Narrative
The treatment tip and data card were returned for evaluation.The data log showed several force errors and thermistor errors occurred during the treatment including: error 128- overforce during rf on.Error 131-underforce during rf on.Error 171-thermistor 1 disconnected.Error 173-thermistor 3 disconnected.Error 211-force too high when button pushed.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, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into ¿action required¿ mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip passed leak and flow testing and visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.Functional testing was performed (50 treatments) with no errors or other issues observed.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.According to thermage cpt user manual, redness, burns, and hyperpigmentation are known possible reactions to treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.Based off the available information, redness, burns, and hyperpigmentation are known possible reactions to treatment.No corrective action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 21316345
• Report Number: 3011423170-2025-00251
• Device Sequence Number: 8435102
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173759
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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