MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE FLX SYSTEM TIP; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TT4.00F6-900
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Erythema (1840); Scar Tissue (2060); Hyperpigmentation (4837)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported redness during a thermage flx treatment to the neck.Post-treatment, the patient experienced hyperpigmentation and scarring.Two cryogen pools, both the size of nickel, were noticed on patient's neck due to cryogen beginning to leak between the handpiece tip carriage and the thermage tip.When the cryogen was removed, the customer noticed both areas were red.The customer elected to stop treatment at that point since they were near the 900-pulse count.The customer provided the patient with hydrocortisone to apply to the two sites.Approximately 6 weeks post treatment (upon return from holiday travel), the patient contacted the user facility to report the two sites appeared to have healed but noticed hyperpigmentation.Treatments with hydroquinone and discovery pico laser were initiated to target persistent pigmentation.Patient photos were reviewed by the solta medical reviewer: day of treatment: mild redness is visible on the side of the neck post-procedure.Five weeks post treatment: two red areas surrounded by brown hyperpigmentation noted.Six weeks, two days post treatment: redness resolved; two mild hyperpigmented areas remain.The patient continues to experience hyperpigmentation and scarring.It is unknown if there will be any permanent damage or scarring.The patient was administered 1000mg of tylenol for the flx treatment.No other treatments (besides the one reported) were being performed in the same area where symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within the past 90 days.No other prior aesthetic treatments have been performed on this area.831 completed reps were reported to have been performed when the cryogen leaked.The highest energy level used was 3.5j (1.5j at time of issue).No system errors occurred.A stamping method was used with solta cryogen and unscented solta coupling fluid.The treatment tip surface was inspected prior to use and there was nothing remarkable to note.The tip was reinspected at about every 30 pulses during treatment.This is the first time the tip had been used.The treatment tip was not kept for return.
Additional Manufacturer Narrative
The tip is not available for an evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
As the product was discarded, no evaluation could be performed.Though requested, the data logs were not returned.Therefore, service is unable to confirm the customer¿s report of leaking cryogen.Should the data logs become available, a follow up report will be filed.According to thermage flx user manual, redness and hyperpigmentation is a known possible reaction to treatment.Redness may occur in a mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer (up to several weeks).Blanching usually resolves within twenty-four (24) hours.Hyperpigmentation usually resolves over the course of time (within several months).No nonconformities 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.
Event or Problem Description
Available pictures were reviewed.Three pictures were provided.Two mildly hyperpigmented areas are visible on the patient¿s neck.Although the hyperpigmented areas are barely noticeable, the case remains classified as serious for the reasons outlined in the previous report.

• Brand Name: THERMAGE FLX SYSTEM TIP
• 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 north 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: 21546348
• Report Number: 3011423170-2025-00253
• Device Sequence Number: 12509458
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: Unknown