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

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Excessive Cooling (2932)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545); Hyperpigmentation (4837)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip was discarded and could not be evaluated.The datalogs were reviewed.It was found the temperature limit was exceeded, thermistor 1 disconnected, and the cryogen can was empty.If the treated area is at or above 40 degrees c., failure to slow treatment speed and/or continuing to treat the same treatment area consecutively can result in an unsafe condition.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 review of the system/data logs does not indicate there is any handpiece or system issue present.Based on the evaluation of the data, the hp and system performed as expected.
Event or Problem Description
A user facility reported blistering and welts on the left upper abdomen of a patient during a thermage cpt treatment.Fucidin h was recommended by the supervising physician and initiated immediately with instructions to apply twice daily.As of eleven days post treatment, the event has resulted in post-inflammatory hyperpigmentation.During the treatment session the handpiece (hp) was dropped.The treatment tip was subsequently inspected and appeared to be intact, with no visible damage.Treatment was then resumed on the abdominal area when the technician observed the development of welts and blisters on the patient¿s skin.Upon noticing these findings, the treatment was immediately discontinued, and the technician discarded the treatment tip.No patient photographs were available.No other treatments (besides the one reported) were being performed in the same area where symptoms were reported.No pain medication or anesthesia was administered.The patient did receive pronox during the treatment.The incident occurred at a level 2.0-3.0, with the highest energy level used as 3.0.An error code stating that the tip was too cold with a warning indicating not to treat the same area appeared and treatment was not done in the same area.A stamping method was used along with 2 bottles of coupling fluid.The tip was inspected prior to use and nothing was noted.The tip was also inspected approximately every 30-50 pulses.This tip was not used to treat any other patients.The tip was discarded.Due to the possibility of permanent scarring, the case was assessed as serious.
Additional Manufacturer Narrative
No treatment tip was returned for evaluation.The datacard logs showed the following errors occurred during treatment: temperature limit exceeded, tm1 disconnected, and cryogen can empty.An error indicates a recoverable problem that requires operator intervention.If the error occurs during an radiofrequency (rf) treatment, the rf delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data, the handpiece and system performed as expected.The datacard logs did not confirm customers account of reported "tip too cold" event code occurred during treatment.According to thermage cpt system technical user's manual, burns, blisters, skin irregularities, redness, and hyperpigmentation are known possible patient reactions to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing 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.A review of the manufacturing records showed all requirements were met.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 corrective action is necessary.

• Brand Name: THERMAGE CPT TIP
• 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: 24339519
• Report Number: 3011423170-2026-00312
• Device Sequence Number: 4876576
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: TTNS3.00E4-1200
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: Unknown