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

Model Number	TTNS3.00E4-900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840)
Date of Event	11/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced redness and potential burns on their forehead after a thermage cpt treatment.Solta medical branded cryogen and approximately 30-40cc of coupling fluid was used with the highest level of treatment at 4.0.The patient received treatment to their face and around the 3rd pass with 110-130 shots delivered, it was observed there was some redness and possible burns or freeze burns on their forehead.No system errors or equipment issues occurred during the procedure.This was the first time the treatment tip was used on a patient, and it was inspected prior to the procedure and every 50 pulses throughout, with no discrepancies found.The patient was given dermosol and prednisolone to treat the injury.They had not received any other treatment in the same symptom area on the procedure date or within 90 days prior.The patient did receive botox treatment to their forehead in the past.Their current status is that there is redness and it¿s unknown if there will be any permanent damage or scarring.
Additional Manufacturer Narrative
The data card and treatment tip have been requested to be returned for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
Though requested, no additional event or patient information has been received.The data card and treatment tip were returned for evaluation.The data log showed several errors had occurred during the event including e076 phase error, e112 rf delivery efficiency, and e211 max tare force exceeded.An error indicates a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency treatment, the radio-frequency 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.Evaluation of the treatment tip found no issues related to this event.The treatment tip passed flow, leak, visual inspection and thermistor tests.No dents, scratches, blemishes, or dielectric membrane breakdown was observed.No functional testing could be performed as the tip had zero pulses left on it.According to the thermage cpt system user manual, burns and redness are known possible adverse patient reactions to thermage cpt 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.Erythema/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.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.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on the available information, burns and redness are known possible adverse patient reactions to thermage cpt treatment.No corrective 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 n creek pkwy n; suite 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; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 20759624
• Report Number: 3011423170-2024-00222
• Device Sequence Number: 15600234
• Product Code: GEI
• UDI-Device Identifier: 00850608002445
• UDI-Public: 00850608002445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: TTNS3.00E4-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown