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

Model Number	TH-6
Medical Device Problem Codes	Leak/Splash (1354); Excessive Heating (4030)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Cryogenic Burn (4539); Skin Burning Sensation (4540)
Date of Event	03/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested multiple times and the customer has not responded.The investigation is ongoing.
Event or Problem Description
A user facility reported a cryogen leakage burn to the right side of the patient's face that occurred during a thermage flx treatment.The nature of the injury was reported as redness, a rash all around the face, bubbling, and sensations of heat and stinging.Secondary intervention included bcn asian centella and b5, and a egf mask to apply post treatment.The patient's current status is uncertain, and it is unknown if there will be any permanent damage or scarring.A consultation follow up was mentioned.An available picture was reviewed by the medical reviewer.Pinpoint brown lesions are scattered on one side of the patient''s face.It is unclear if the lesions are crusts or post inflammatory hyperpigmentation.No other treatments (besides the one reported) were performed in same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days.The patient has not had prior aesthetic treatments on the affected area.The incident occurred at 193 reps.The highest energy level used was 2.5 mj.Additionally, an error message of "tip too warm" occurred during the treatment.
Event or Problem Description
Additional information has been received indicating that the patient is fine with no scarring or long-term effects.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event no longer meets reportability requirements.
Additional Manufacturer Narrative
Correction: section d - 4 model number from tg-3a to th-6.Correction: section d - 4 serial number from bbc9bg to bbc9c5.Correction: section d - 4 udi from 00816995020639 to 00816995021278.Correction: section h - health effect impact code 1 from 4614 to 4613.The data logs were reviewed and based on the evaluation of the data, the hand piece and the system performed as expected.Despite multiple requests, the treatment tip and the hand piece were not provided for evaluation at the time of this investigation.Therefore, the customer''s report of cryogen leaking could not be confirmed.However, "tip too warm" errors that occurred during the treatment were confirmed by the data logs.According to thermage flx system user manual, burns are known possible side effects 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.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.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 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste. 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 19140068
• Report Number: 3011423170-2024-00147
• Device Sequence Number: 13121111
• Product Code: GEI
• UDI-Device Identifier: 00816995021278
• UDI-Public: 00816995021278
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: TH-6
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female