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

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Swelling/ Edema (4577); Hyperpigmentation (4837)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported redness, swelling, and burns that were observed on the right side of the patient¿s face during a thermage cpt treatment.It was reported that during the procedure, the patient didn't initially feel any heat with the treatment starting at 4mj, the energy was gradually increased to 8mj.When the treatment reached 300 shots the patient described it as a pricking sensation, but the physician considered it to be a normal response.The physician checked the treatment tip, and it was found to be undamaged; however, after the patient continued to feel the pricking sensation, the treatment was stopped, and it was observed that the treatment tip was damaged.Immediately after the treatment, the area became red and swollen.Unscented solta coupling fluid was used to complete the treatment.No other treatments (besides the one reported) were performed in the same area where symptoms were reported within the past thirty days.No other errors or abnormalities were observed during the treatment.It was reported that epithelialization was performed, and no scarring is expected.Available pictures were assessed by the solta medical reviewer, which identified post inflammatory hyperpigmentation that resulted from the burned areas.The patient¿s current status was reported as chromatosis and an unknown secondary treatment was reported.The other side of the patient¿s face was treated with a new treatment tip, and there was no scalding sensation.
Additional Manufacturer Narrative
The treatment tip and data logs are not available for evaluation.The investigation is underway.
Additional Manufacturer Narrative
The investigation is ongoing as the treatment tip has been requested for evaluation.However, no supplemental reports will be submitted as this event no longer meets reportability requirements and no serious injury occurred.
Event or Problem Description
The patient reported having no further issues or concerns.Additionally, the physician indicated that no scarring was expected.No treatment beyond the standard of care was reported.Based on the new information, the solta medical reviewer concluded that this event is not a serious injury.The event no longer meets reportability requirements.

• Brand Name: THERMAGE CPT 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 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 21314477
• Report Number: 3011423170-2025-00250
• Device Sequence Number: 8083950
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: TTNS3.00E4-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Female