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

Model Number	TT16.00F6-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data log from the event was returned for evaluation.The data showed several error codes occurred during treatment including: ec78b-tip force too low, ed4c8-rf gen power error, ed4cd-rf gen max power delivered, ec785-tip lifted prematurely, ec78d- activation button timed out, and ed4c2- gen tuning failure.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.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.The two most common error codes that appeared during the treatment were ed4c8-rf gen power error, and ed4cd-rf gen max power delivered.The user must hold the handpiece still during the radio-frequency delivery state.Any slippage or insufficient treatment tip contact to the treated area during the radio-frequency delivery state, would cause an under treatment or over treatment event.Based on the evaluation of the data, the system and handpiece perform as expected.The treatment tip was not available to return for evaluation.A review of the manufacturing records showed all requirements were met.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No solta serial number was provided for this event.According to the thermage flx system user manual, burns and blisters are a known possible side effect of 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.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 experienced multiple 2nd degree burns on their abdomen following a thermage flx body treatment.The report was received approximately 65 days post-procedure, it is unknown when symptoms were first observed.The patient was given an unknown ointment for their injuries and heat or ice was applied post procedure.The patient did not treat their burn with any over the counter solutions at home.Their current status is they are undergoing laser treatment and gradually recovering.Permanent damage or scarring is expected.No other treatments were performed in the same symptom area on the procedure date or within 90 days prior.The patient does not have a history of receiving aesthetic treatments in the symptom area.Information for the cryogen and coupling fluid used in the treatment were not provided.It is unknown if a stamping or sliding method was used.The patient was not administered any pain medication or anesthesia prior to the treatment.They were alert and able to provide feedback during the procedure.The highest level of treatment was 5.5.No system errors occurred during the treatment.It is unknown if this was the first time the body treatment tip was used on a patient and it¿s unknown if it was inspected prior to the procedure or at any time during.

• 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 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: 21663802
• Report Number: 3011423170-2025-00258
• Device Sequence Number: 7694925
• Product Code: GEI
• UDI-Device Identifier: 00816995021360
• UDI-Public: 00816995021360
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170758
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: TT16.00F6-500
• 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: 02/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female