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

Model Number	TR-4
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060); Hyperpigmentation (4837)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tip was discarded.The investigation is underway.
Event or Problem Description
A user facility reported a burn to the patient''s upper back, below the neck and on the area where the return pad was attached during a thermage flx treatment.An available picture was reviewed by the medical reviewer.An open wound is visible on the back area below the neck.A hyperpigmented area is also visible.It is unknown if the hyperpigmented area is related to this event or was existing prior to this event.It is reported that a burn occurred on the same area where the return pad was attached behind the neck after undergoing a 600-shot thermage about a year ago, but this burn occurred again in the same area.Sleep anesthesia was given to the patient.The area that was treated was the face.No secondary intervention (ointments, medications, etc.) was required to treat this event.It is unknown if there will be any permanent damage or scarring.No other treatments (besides thermage) were being performed in the same area where the symptoms were being reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used 3 mj.No system errors occurred nor was anything out of the ordinary noticed during treatment.Solta medical croygen and coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and there was nothing remarkable.The treatment tip surface was inspected during the treatment at about every 100 shots.This is the first time this treatment tip was used.The treatment tip was not kept.
Additional Manufacturer Narrative
Correction to d4.The initial mdr was against the treatment tip.As the burn was in the location of the return pad, d4 has been updated to the return pad.The data log was returned for evaluation.Evaluation of the data log found that the handpiece and system performed as expected and confirmed no errors occurred during treatment.The tip and return pad were not returned for investigation.According to thermage flx system user manual, burns are known possible side effects 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.The thermage flx system user manual also warns customers to not use local injections or tumescent anesthetic or nerve block techniques to manage patient comfort during the thermage procedure.Use of these types of pain management techniques increases the risk of tissue injuries.The thermage flx system user manual instructs the customer to select a location for the return pad that is a well-vascularized area and has minimal curvature, for example, the lower back area, or side (just above the hip) that is free of hair, free of tattoos, and completely dry.The return pad should not be placed near shoulder, neck, head regions, legs, or arms.The user should give special attention to the return pad for signs of heating.The patient should feel no sensation of heat at the return pad during treatment.If patient reports feeling heat or electrical stimulus at the return pad site, stop treatment and verify placement and cable connections.It was reported the patient was placed under sleep anesthesia.The user manual warns users to not use local injections or tumescent anesthetic or nerve block techniques to manage patient comfort during the thermage procedure.Use of these types of pain management techniques increases the risk of tissue injuries.Patient feedback regarding their perception of heat or discomfort during the procedure is an essential input to guide the user in determining safe and effective treatment levels.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.As the serial number is unknown, a review of the device history record could not be performed.Based on the available information, this treatment was performed in an off-label manner.At this time, no capa is necessary.
Event or Problem Description
The patient is still under treatment at a burn clinic.The burn was deeper than expected, and treatment has not yet been completed.The patient is recovering, but a permanent scar is expected.The doctor confirmed that the return pad was attached to the upper back.The return pad clip was touching the patient''s neck and the burn was not identified until late because the patient was under general anesthesia.

• 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; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n 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: 19143454
• Report Number: 3011423170-2024-00149
• Device Sequence Number: 20783669
• Product Code: GEI
• UDI-Device Identifier: 00816995021285
• UDI-Public: 00816995021285
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170758
• 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): 03/25/2024

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: TR-4
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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