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

Model Number	TT0.25F6-450
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Localized Skin Lesion (4542); Swelling/ Edema (4577); Hyperpigmentation (4837)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient presented approximately four and a half weeks after a thermage flx eye treatment performed by another physician, at which time post-inflammatory hyperpigmentation of the left lower eyelid was observed.The patient also reported experiencing redness, swelling, and significant pain immediately following the procedure.Immediately after treatment, secondary intervention included application of an ice pack to the affected area.A skin booster treatment was performed on the day the hyperpigmentation was identified four and a half weeks post-treatment.At approximately three and a half months post-procedure, the patient¿s condition was reported to be improved; however, residual hyperpigmentation remained, and permanent damage or scarring may be expected.Although improvement was noted, the presence of residual hyperpigmentation classifies the event as serious and meeting reportability requirements.An available photograph was reviewed by the solta medical reviewer.The image showed a localized hyperpigmented lesion in the left infraorbital region, just inferior to the lower eyelid, measuring approximately 5¿8 mm in diameter, with mild surrounding erythema.The treatment was completed using an xs thermage eye shield and genteal tears.The highest energy used was 3.5 mj, using the stamping method.This was the initial use of the treatment tip, which was inspected prior to use and approximately every 50 shots, with no abnormalities observed.The user facility confirmed the use of solta cryogen and approximately half a bottle of unscented solta coupling fluid.The patient was not administered pain medication or anesthesia during the procedure.Between approximately 300¿400 shots, an unusual squeaking sound was noted from the handpiece, at which time the patient reported significant pain.It was also reported that the patient had undergone mesotherapy in the same area within 90 days prior to the treatment.Based on the reported information, the patient was not taking any oral medications, supplements, or topical products.
Additional Manufacturer Narrative
The treatment tip was not returned for evaluation.A review of the system datalogs identified two occurrences of ¿activation button timed out,¿ one occurrence of ¿treatment tip lifted prematurely,¿ one occurrence of ¿treatment tip force high,¿ and five occurrences of ¿treatment tip force low.¿ when the system detects a condition that interrupts treatment, an error code is displayed.These codes provide the corresponding error number and instructions for appropriate user response.In such instances, user intervention is required to proceed.Based on the evaluation of the datalog, the system and handpiece performed as expected.The datalog did not indicate any abnormalities that would correspond to the reported unusual squeaking sound, and no performance issues were identified.A review of manufacturing records confirmed that all requirements were met.The trend analysis, risk analysis, and directions for use review were considered acceptable, with the product performing within anticipated rates.According to the thermage flx user manual, hyperpigmentation, pain, swelling, and redness are known possible reactions to treatment and typically resolve over time.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 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: 24841815
• Report Number: 3011423170-2026-00322
• Device Sequence Number: 21282038
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: TT0.25F6-450
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: Male