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

Model Number	TT4.00F6-900
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reportedly experienced a blister below the left temple post thermage flx facial and neck treatment.A patient photo was reviewed by the solta medical reviewer.A blister is visible on the temple area; however, the quality of the picture is insufficient to evaluate the blister thoroughly.Other areas of the patient's face appear erythematous.Mupirocin and biafine ointment were used to treat the patient¿s blister.The patient is currently described as ¿within normal limits,¿ which was not defined.It is unclear yet if there will be permanent damage or scarring.The highest energy level used was 2.5.The incident occurred within the first 135 reps or up to 215 reps.When eight reps were left, a crackle sound was observed when treating the patient¿s forehead.Solta cryogen and 7 bottles of solta coupling fluid were used.The treatment tip was inspected prior to use, with nothing atypical noted, but was not inspected during the treatment.This treatment was the initial use of the treatment tip.No other treatments were being performed in the same symptom area.The patient had not had aesthetic treatments within the prior 90 days.The patient had a thermage treatment approximately two years prior.
Additional Manufacturer Narrative
The treatment datalogs were reviewed.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.The following error messages occurred during the treatment: quantity - error id - description - percent of reps; 3 - ec78e - err_force_before_activation - 0.33%; 4 - ec78c - err_treatment_tip_temp_high - 0.44%; 17 - ec785 - err_treatment_tip_lifted_prematurely - 1.89%; based on the evaluation of the data, the system and handpiece perform as expected.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Cryogen appeared to be flowing during the treatment.The treatment tip was returned and evaluated.The tip passed leak testing, thermistor testing, and visual inspection.No dents, scratches, blemishes, or dielectric breakdown were observed.The tip was unable to be functionally tested as there were no reps remaining.The investigation is ongoing.
Additional Manufacturer Narrative
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.Cryogen appeared to be flowing during the treatment.Based on the data, errors could have been user technique related.Service could not confirm the reported crackling sound.Based on the evaluation of the data, the system and handpiece perform as expected.Evaluation of the treatment tip found no issues related to this event.A review of the manufacturing records showed that all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.The lot/device history review and trend analysis are considered acceptable, and the product is performing within anticipated rates.According to thermage flx user manual, blisters are a known possible side effect 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.Based on the available information, blisters are a known possible side effect during thermage flx treatment.No corrective action is necessary at this time.
Event or Problem Description
The doctor at the reporting facility has confirmed that the patient has no scarring or permanent damage.This event is no longer considered a serious injury and therefore no longer meets reportability requirements.

• Brand Name: THERMAGE FLX (TG-3A) AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• 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: 21105443
• Report Number: 3011423170-2025-00241
• Device Sequence Number: 21028251
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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