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

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced grid-like pattern scabbing on the left cheek and neck area following a thermage cpt treatment.Thermage was performed on the patient's full face and neck no issues noted.The left face had been treated first.The day following the treatment the patient observed scabbing on the left side of their face and neck in a grid-like pattern.There was no injury of the right face or right neck.It is unknown if any secondary intervention was applied or prescribed after the injury was reported.The patient did not receive any other treatment to the same symptom area on the procedure date or within 90 days prior.The patient does receive thermage treatments in the same symptom area every 6 months for the past 5 years on the same treatment settings with no history of adverse events.Their current status is the injury has improved and the skin is still healing.It is unknown if there will be any permanent damage or scarring.Solta medical branded cryogen and a ¿generous¿ amount of coupling fluid was used with the highest level of treatment at 2.0.No system errors occurred during the procedure.This was the first time the treatment tip was used on a patient.The provider believes the tip was inspected prior to use and was inspected again during the treatment however, it is unknown how often it was checked.No discrepancies on the tip were reported.
Additional Manufacturer Narrative
The treatment tip from the event was discarded.The event data logs have been requested to be returned for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
Multiple attempts were made to obtain further information regarding the patient event and data logs but they were unsuccessful, and it appears no response will be forthcoming.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No solta serial number was provided for this event.According to the thermage system technical user¿s manual, scabbing is a known possible adverse patient reaction to thermage treatment.Erythema or blanching may occur in 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.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No correction action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM 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: 21473149
• Report Number: 3011423170-2025-00252
• Device Sequence Number: 8659038
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown