MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TT0.25F6-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Swelling/ Edema (4577); Hyperpigmentation (4837); Dry Skin (4839)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip was discarded at the customer site and not available for evaluation.The data logs from the event were reviewed and showed several errors occurred during the procedure.Errors logged were ec78a-tip force high, ed4c2-tuning failure, and ed4cf-rf under delivery.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece perform as expected.According to thermage flx user manual, burns, redness, swelling, and skin discoloration are known possible side effects during a thermage flx 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.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.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.Based on the available information no causal factors can be determined and no conclusions can be drawn.No corrective action is necessary at this time.
Event or Problem Description
A user facility reported that a patient had received thermage flx eye treatment and experienced burns on both of their upper and lower eyelids following the procedure.The patient reported the injury to the clinic three days post-procedure.No secondary medical intervention was reported.The patient¿s status is they have a burn injury on both upper and lower eyelids and there is a possibility of permanent damage or scarring.No other treatments were performed in the same symptom area on the procedure date or within 90 days prior.The patient does not have any history of previous aesthetic treatments in the symptom area.A solta medical reviewer examined an image of the patient injury.Bilateral involvement of the upper and lower eyelids was visible.Observation findings included erythema of the upper eyelids, areas of superficial crusting along the eyelid margins, and patchy hyperpigmentation in the periorbital regions.Mild eyelid edema is also suspected.The medical reviewer could not determine healing progression from the image however suspected there was a potential risk for post-inflammatory pigmentary alteration and possible scarring.Solta medical branded cryogen and 33% bottle of coupling fluid was used, with the highest level of treatment at 2.0.No system errors occurred during the procedure.This was the first time the treatment tip was used on a patient, and it was inspected prior to use, and every 50 pulses, with no discrepancies found.This event meets reportability requirements as the medical reviewer has deemed it a serious injury.
Additional Manufacturer Narrative
The investigation and conclusions from our initial assessment remain unchanged.
Event or Problem Description
An updated status on the patient was received.It was reported the patient is currently receiving burn treatment in taiwan, and that their condition has improved significantly compared to the initial state.Details of the treatment were not provided.A solta medical reviewer examined updated photos of the patient and observed the patient showed marked improvement.Facial swelling had substantially decreased, particularly in the periorbital areas.Erythema was diminished, and the previously inflamed regions appeared less irritated.Residual mild discoloration and healing lesions were present, but the overall skin integrity had improved.
Event or Problem Description
An updated status on the patient was received.It was reported the patient is still currently receiving burn treatment in taiwan and have almost fully recovered.There is a low chance of any permanent damage or scarring.Details of the treatment were not provided.
Additional Manufacturer Narrative
The investigation and conclusions from our initial assessment remain unchanged.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 24649884
• Report Number: 3011423170-2026-00317
• Device Sequence Number: 15969988
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170758
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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: TT0.25F6-450
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 05/04/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/21/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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