MAUDE Adverse Event Report: Solta Medical, Inc. Thermage FLX (TG-3A) System and Accessories; Electrosurgical,Cutting & Coagulation & Acc.

Model Number	TT16.00F6-500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Partial thickness (Second Degree) Burn (2694); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545); Hyperpigmentation (4837)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two treatment tips and datacard logs were returned for evaluation.The treatment tips passed the leak and thermistor testing.The thermage tips passed visual inspection.No dents, scratches, blemishes, or dielectric breakdown observed.\ \ evaluation of the two treatment tips found no issues related to this event.\ \ the datacard log showed the following errors occurred during treatment: tip #1 - crit write check error, treatment tip ow epprom crc error, force activation button timed out arm, force before activation, and gen tuning failure.Tip #2 - treatment tip lifted prematurely, activation button timed out arm, and force before activation.\ \ 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.The datacard log confirmed the customer¿s account of ec2026 (invalid treatment tip) and e2212 (crit write check error) occurring during treatment.Service evaluation found one thermistor cold in some time 2 of the thermistors are cold when other thermistors show hot.E2212, ec206 and ed4c2 (gen tuning failure) could possibly occurred because of the user treatment technique (sliding technique).\ \ based on the evaluation of the data, the system and handpiece perform as expected.\ \ according to thermage flx user manual, burns, blisters, and discoloration are known possible reactions to 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.\ \ the thermage flx user manual also provides users with guidance on use of anesthesia during treatment and states 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.Additionally, customers should use a stamping method with the tip and handpiece to treat the patient.After radiofrequency delivery, the user should lift the treatment tip away from the patient¿s skin.\ \ use of intravenous anesthesia for pain management techniques increases the risk of tissue injuries.Additionally, customers should use a stamping method with the tip and handpiece to treat the patient.\ \ a review of the manufacturing records showed all requirements were met.No nonconformities or anomalies were found related to this event 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 evaluation of the system datacard and tip, this event was not caused by the thermage flx system.Based on the available information, this event was performed in an off-label manner that caused risk to the patient.\ \ at this time, no capa is necessary.
Event or Problem Description
A user facility reported patient multiple burns and lesions approximately 20mm in diameter to the abdomen 1 day post thermage flx treatment.\ \ a subsequent clinical assessment revealed that the patient sustained minor second-degree burns presenting as blisters.To address this adverse event, a secondary medical intervention was deemed necessary.At a follow-up evaluation, the patient was prescribed oral medications to manage the healing process; however, the exact medication was not reported.The status at the time of the evaluation was reported to be stable, and the clinical expectation was that there will be no permanent damage or long-term scarring.\ \ available images were reviewed were reviewed by the medical reviewer.One contains two photographs dated one day post treatment, which capture the patient's abdomen at the onset of symptoms.The upper and lower panels display numerous erythematous, ring-shaped imprints approximately 20 mm in diameter scattered across the abdominal wall, with a distinct, fluid-filled blister visible along the lower midline.The other image shows the progression of the abdomen three days later.The multiple circular lesions have turned a darker, hyperpigmented shade with minimal surrounding redness, and the prominent lower blister has deflated, forming a flattened, dark brown crust.The final image illustrates the abdomen six days after symptom onset.This image shows a white topical cream applied to the lower healing lesion, while the surrounding circular marks continue to show signs of healing and stabilization under the prescribed therapeutic regimen.\ \ a follow-up image depicts the patient's anterior abdominal wall and demonstrates the status 19 days post treatment of treatment sites.Several circular lesions are visible across the abdomen, consistent with the previously affected areas.The lesions appear to be in different stages of healing, with multiple sites showing dark brown to black dry crusts.One lesion in the lower central abdomen remains the largest and is characterized by a well-demarcated oval area covered by a dark dry crust (black scab), with mild localized surrounding erythema.A smaller central lesion demonstrates superficial crusting with a small amount of dried exudate.The remaining lesions appear dry without visible active drainage or bleeding.Linear striae are present across the abdomen and are considered unrelated to the reported event.Overall, the follow-up image suggests interval progression toward healing of the affected sites, with persistent dry crust formation and residual mild surrounding erythema.No obvious extensive surrounding cellulitis or purulent drainage is visible in the photograph.\ \ the patient returned for a follow-up evaluation, approximately thirty three days post treatment, at which time wound photographs were obtained to document the healing progress.During a subsequent follow-up visit thirty four post treatment, the physician observed raised tissue at the wound site.Following clinical evaluation, debridement was performed to remove the affected tissue and support the healing process.The patient was seen again thirty nine days post treatment for follow-up after the debridement procedure.At this visit, the first platelet lyophilized treatment (plt) session and a picosecond laser treatment were performed.The treating physician established a plan for a total of six plt sessions, to be administered every 3 to 7 days, with the goal of promoting wound healing and tissue repair.Clinical assessment at the clinical evaluation follow-up indicated that no blisters were present in the remaining treated areas.The primary residual finding was post-inflammatory hyperpigmentation.The physician plans to address the hyperpigmentation with additional picosecond laser treatments during future follow-up visits.At the time of the most recent evaluation, the patient was continuing treatment as planned with ongoing clinical monitoring.\ \ additional images were reviewed from thirty three days post treatment and revealed a circular open wound located on the lower abdomen.The wound bed contains visible yellow slough within the central portion, with surrounding erythema extending around the wound margins.The wound remained open and demonstrated tissue requiring continued monitoring and wound care.Images from the clinical evaluation showed the wound bed appears cleaner with increased healthy red granulation tissue and a reduction in visible yellow slough.The surrounding tissue remains mildly erythematous but does not demonstrate obvious progression of inflammation based on the photograph alone.The wound remains open but appears to be undergoing the expected healing process.\ \ no other treatments, besides the one being reported, were performed in the same area where symptoms were reported.The user treated the face with one total tip 4.0 (900 reps) and eyes with two eye tips 0.25 (450 reps each).The patient has not undergone any other treatments in the same symptom area within the past 90 days, nor has the patient ever had prior aesthetic treatments in this area.The patient was administered iv anesthesia, prednisolone and keflex.\ \ at rep 11, an ec206 error (invalid treatment tip) occurred.Following the on-screen instructions, the main power was turned off, and the system was rebooted after waiting 2 minutes.\ at rep 56, the ec206 error reoccurred.Following the same steps, the main power was turned off, and the system was rebooted after waiting 2 minutes.\ at rep 173, an e2212 error (err-crit-write-check) occurred.Due to multiple consecutive errors, the engineer was contacted.Per their recommendation, the system was powered down to wait for 10 minutes, and the entire handpiece slot was detached.\ at rep 250, the ec206 error reoccurred.As the error persisted, use of this tip was discontinued, and it was replaced with another tip.\ \ the highest energy level used was 3.5 kj at first, followed by 2.0 kj.The treatment was performed using a sliding method.Solta flx cryogen and 1.5 bottles of solta coupling fluid were used.The treatment tip surface was inspected prior to use and there was nothing remarkable to report.The treatment tip surface was inspected prior to treatment and during the treatment at about every 50 pulses and was not used on any other patients prior to this treatment.\ \ the case was assessed as a serious case due to the prolonged treatment and requirements for secondary interventions beyond standard of care.

• 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 ; +1(425)420-2135
• MDR Report Key: 50382472
• Report Number: 3011423170-2026-00336
• Device Sequence Number: 15893713
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: TT16.00F6-500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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