MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TT4.00F6-900
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Erythema (1840); Blister (4537)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced a red blister of the right temple the day after a thermage flx treatment of the face and neck.The patient applied aquafor at home and was given exosomes during a follow up appointment.Four weeks post procedure, the patient was given additional exosomes.At that time, the patient was still healing and seemed to be getting better.The patient reportedly experienced redness and bruising during the healing process.During the treatment, tip too warm error(s) occurred.The highest level of treatment was 2.5-3.0.Solta medical branded cryogen was used with an unknown total amount of coupling fluid.Coupling fluid was applied on every pass and before every vector.This was the first time the treatment tip was used on a patient, and it was inspected prior to use with no discrepancies found.The tip was not inspected at any time during the treatment.The patient had not received any other treatment to the symptom area on the procedure date or within 90 days prior.The patient has historically received quarterly clear and brilliant treatments with application of benzocaine, lidocaine, and tetracaine (blt) cream prior to the treatment.
Additional Manufacturer Narrative
The treatment tip and data log from the event are not available for evaluation.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.According to the thermage flx system user manual, burns and blisters are a known possible side effect of thermage flx treatment.The procedure produces heating in the upper layers of the skin, and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Provider¿s report of ec78c (tip too warm) error could not be confirmed since data card logs were unavailable for return.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is necessary at this time.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 21246621
• Report Number: 3011423170-2025-00248
• Device Sequence Number: 14359402
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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: TT4.00F6-900
• 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: 12/30/2024
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female