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

Model Number	TT4.00F6-900
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Excessive Cooling (2932); Excessive Heating (4030)
Health Effect - Clinical Codes	Erythema (1840); Full thickness (Third Degree) Burn (2696); Blister (4537)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported burns, blisters, and erythema on both sides of the lateral neck immediately after a thermage flx treatment of the face and neck.The incident occurred after 200 shots with the highest energy being 3 mj on the face and 1.5 mj on the neck.It was noticed that during the procedure that ¿tip too warm¿ and ¿tip too cold¿ error messages occurred.It was reported that cryogen and approximately 30ml of coupling fluid was used.The treatment tip surface was inspected prior to use and approximately every 200 pulses throughout the treatment, and nothing out of the ordinary was noted.The tip used during this treatment was not used on used on other patients.The tip was not kept by the user facility; therefore, it cannot be returned for evaluation.The patient was reportedly placed under anesthesia for the thermage treatment.No other treatments (besides the one reported) were performed in the same area where symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within ninety days prior to the treatment.It was also reported that the patient has not had prior aesthetic treatments.The patient reportedly experienced 3rd degree burns with the possibility of permanent scarring.The patient was treated with cold compresses and clobetasol 0.05%.Available pictures were reviewed by the solta medical reviewer, which concluded that erythema, burned areas, and blisters are visible on the lower side of the neck.It was later reported that it took approximately one month to treat the burn on the patient until it healed.The patient has completely recovered and there are no longer any marks on the affected area.The medical reviewer has assessed the case as serious due to the treatment outside of standard of care as well as the length of healing time.
Additional Manufacturer Narrative
The investigation is underway.
Additional Manufacturer Narrative
The data card log confirmed the tip too warm and tip too cold event codes occurred during the treatment.If a treatment tip¿s thermistors exceed the maximum and minimum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a tip too warm or tip too cold code and place the system into a safe state.This condition presents no patient risk.When the system detects a condition that interrupts the 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 performed as expected.It was reported by a regional engineer that cryogen was flowing properly, flowing to the tip during testing, and the unit was functioning properly.According to the thermage flx user manual, burns and redness 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.It was reported the patient was under anesthesia.The thermage flx user manual warns users to not use local injections or tumescent anesthetic or nerve block techniques to manage patient comfort during the thermage procedure.Use of these types of pain management techniques increases the risk of tissue injuries.Patient feedback regarding their perception of heat or discomfort during the procedure is an essential input to guide the user in determining safe and effective treatment levels.Based on the available information, this treatment was performed in an off-label manner that resulted in unsafe conditions for the patient.No non-conformities or anomalies were found related to this complaint 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.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 n creek pkwy n; ste 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; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 19772639
• Report Number: 3011423170-2024-00190
• Device Sequence Number: 8428747
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: TT4.00F6-900
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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