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	Noise, Audible (3273)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Scar Tissue (2060)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been requested.The investigation is underway.
Event or Problem Description
A user facility reported that a burn to the patient's left eyelid occurred during a thermage flx treatment.Review of a patient image by the solta medical reviewer photograph notes that there is demonstrated erythema, and a wound located beneath one eye.As of nearly one month post treatment, the patient is still under treatment at a burn hospital, with not much improvement noted.As the burn occurred in the delicate periocular area, a permanent scar is expected.No other treatments (besides the one reported) were being performed in same area where symptoms were reported.The patient was not administered any pain medication or placed under anesthesia.An eye shield was used, and the type of eye shield lubrication is unknown.The incident occurred after 100 reps on the left periorbital area, to which a burning sound "bzzz" was heard.The highest energy level used was 2.0.Temporary error messages were reported, but the user is not sure about the exact error type.A stamping method was used.30 ml of unscented solta coupling fluid was utilized.The treatment tip surface was inspected prior to use and there was nothing to note.The treatment tip surface was reinspected during the treatment every 100 reps.This is the first time the treatment tip had been used.
Additional Manufacturer Narrative
The treatment tip associated with this event was not returned for evaluation.Datacard logs were returned for evaluation.The datacard log showed the following errors occurred during treatment: temperature tip force high, temperature tip force low, tip temperature too high, and general tuning failure.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, blisters are a 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.No nonconformities or anomalies were found related to this event 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.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 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: 22923607
• Report Number: 3011423170-2025-00297
• Device Sequence Number: 9079449
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: TT0.25F6-450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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