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

Model Number TT4.00F6-900

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The product was discarded.The investigation is ongoing.

Event Description

A user facility reported a burn to the face a few days after a thermage flx treatment.The area of the body was that was treated was the face.No secondary intervention (ointments, medications, etc.) was required to treat this event.Due to limited information, it is unknown if there will be any damage or scarring.An available picture was reviewed.A wound is visible on temporal area.The exact status of the wound is not clear due to low quality of the picture.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.It is unknown if the patient has undergone any other treatments in the same symptom area within the past 30 days.The incident is reported to have occurred after 900 reps.The highest energy level used was 2-2.5 mj.A tip too warm error was generated during treatment.Solta medical croygen and 30ml of 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 about 50 reps during the treatment.This is the first time this treatment tip was used.The treatment tip was not kept for return.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: 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: 19125967
• MDR Text Key: 340393096
• Report Number: 3011423170-2024-00144
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1