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 Codes	Burn(s) (1757); Erythema (1840); Blister (4537); Hypopigmentation (4838)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data log and treatment tip have been requested to be returned for evaluation.The data log was reviewed from the event.Several errors occurred during the procedure including; ec78e-force before activation, ec785-treatment tip lifted prematurely, ec78b- treatment tip force low, ed4c2- gen tuning failure, and ec781-activation button timed out.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 handpiece and system performed as expected.The treatment tip was evaluated and passed leak and thermistor testing however failed visual inspection due to a glue issue.Service found a foreign object in the glue but this would not result in any issues since radio-frequency energy was still able to distribute evenly across the tip membrane.No dents or dielectric breakdown was observed.No functional testing could be performed due to the tip having no more pulses left.According to thermage flx user manual, burns and blisters are know potential reactions to 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, this event is known potential reaction to thermage flx treatment.No corrective action is necessary at this time.
Event or Problem Description
A user facility reported that a patient experienced a burn to their supraumbilical area during a thermage flx body treatment.The patient had received thermage flx treatment to their abdomen and legs.After the injury occurred, the patient was treated with la roche-posay branded cicaplast balm.The patient¿s current status is they are healing however hypopigmented spots are expected.The patient takes magnesium and hydrolyzed collagen, as well as applying moisturizing cream, on a daily basis.The patient has not received any other treatment to the same symptom area on the procedure date or within 90 days prior.The patient has never received treatment to the same symptom area in their past history.A solta medical reviewer examined two images of the patient¿s abdomen.One image showed a blister around the umbilicus, while the other depicted a small blister with surrounding erythema.No dates were provided for the images.Solta medical branded cryogen and 4 bottles of cryogen were used with the highest level of treatment at 1.5.The injury reportedly occurred during the ¿first pass¿ in the abdomen area.It is not known if the provider used a stamping or sliding method.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, with no discrepancies observed.The tip was not checked again during the procedure.

• 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: 22979940
• Report Number: 3011423170-2025-00298
• Device Sequence Number: 15795480
• Product Code: GEI
• UDI-Device Identifier: 00816995021360
• UDI-Public: 00816995021360
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/14/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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: Female