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

Model Number TT0.25F6-450

Device Problems Radiation Output Problem (4026); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

The device was taken by the patient and is unable to be evaluated.The investigation is ongoing.

Event Description

A user facility reported that a patient experienced a burn with blistering on the left lower eyelid during a thermage flx treatment.Available pictures were reviewed by the medical reviewer and erythema and inflammation were visible on the patient''s face.In a second picture provided, a blister was visible on the lower eyelid of one eye.An eye shield and cloroph eye shield lubrication were used.Encain topical numbing cream was applied to the patient.Secondary intervention includes lucas papaw/ointment.The patient''s current status is reported that the affected area is forming scar tissue; however, it is unknown if there will be any permanent damage or scarring.No other treatments (besides the one reported) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days.The incident occurred after 230 shots with the highest energy of 2.5 mj being used.Additionally, radiofrequency power errors, under deliver errors, and tip too warm errors occurred during the treatment.The user tried to reapply the return pad when they first saw the error code and replaced it with a new return pad when they saw a similar warning again.The stamping method, tc-2-4 cryogen, and a massive amount of unscented coupling fluid were used.The surface of the treatment was inspected prior to use, and nothing was noticed.The treatment tip surface was reinspected during the treatment and the user changed to new tips when they saw that the warning errors didn¿t go away.The same individual tip has not been used to treat other patients.The individual treatment tip was not kept as the patient insisted on keeping it.

• 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 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: 19142952
• MDR Text Key: 340590716
• Report Number: 3011423170-2024-00148
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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 Assistant
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female