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

Model Number	TTNS3.00E4-1200
Medical Device Problem Codes	Material Discolored (1170); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Tears (2516)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported a severe reaction and what looks like some minor burns and cuts on the right side of the face 1 day post treatment.The left side of the face didn't appear to have any serious issues at the time of the report.However, the right side of the face had more serious damage.Secondary intervention included skinceutical's epidermal repair cream and skinceutical's phyto gel for the patient to use.The report noted that there is a possibility of a permanent scar.Available pictures were reviewed by the medical reviewer and shows erythema, burned areas, and cuts on the right side of the face, neck, and forehead.No other treatments (besides the one reported) were being performed in same area where symptoms were reported.The patient has undergone unspecified treatments in the same symptom area within the past 90 days.The patient has not had prior aesthetic treatments on this area.Two tylenol pills were administered to the patient for the treatment.The highest energy level used: 5.5 mj.The technician who did the treatment did not notice that the tip had a white spot in the middle until the treatment was complete.A system error also occurred after the cryogen can was changed.Solta cryogen and 1 bottle of unscented coupling fluid were used.Both a stamping and sliding method were used during treatment.The treatment tip surface was inspected prior to use and unremarkable; however, the tip was not inspected during the treatment.The tip has not been used to treat other patients.
Additional Manufacturer Narrative
Medical device problem code: 3191 unspecified error message by user.The product has been requested and the investigation is underway.
Additional Manufacturer Narrative
The treatment tip and data log were returned for evaluation.Evaluation of the tip showed it passed the flow, leak, and thermistor tests.Service observed a dent on the tip membrane.It is unlikely that the dent contributed to this event since the radiofrequency energy was able to distribute evenly across the tip membrane.No dielectric breakdown observed.The data log evaluation showed the following errors occurred during treatment: quantity - error id - description - percent of reps 1 - 76 - tip lifted/tilted during rf on - (b)(4).5 - 128 - overforce during rf on - (b)(4).3 - 131 - underforce during rf on - (b)(4).6 - 132 - underforce during post cool - (b)(4).An error indicates a recoverable problem that requires operator intervention.If the error occurs during a radiofrequency treatment, the radiofrequency 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 display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data log, the system and handpiece performed as expected.According to the thermage cpt 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.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.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.No nonconformities or anomalies were found related to this complaint 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 available information, burns and redness are known possible adverse patient reactions to thermage cpt treatment.At this time, no capa is necessary.

• Brand Name: THERMAGE CPT SYSTEM
• 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 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 20077952
• Report Number: 3011423170-2024-00202
• Device Sequence Number: 18032668
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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