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

Model Number TT0.25F6-450

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip has been requested and is expected to be returned and evaluated.The investigation is ongoing.

Event Description

A user facility reported burns around the skin of the eyes post thermage flx treatment.An available video of the patient was reviewed by the medical reviewer.It is noted that there is erythema visible on the patient's cheeks and around the eye.Crusted areas were also visible on the side of both upper eyelids.Additional information has been requested regarding this event.

Manufacturer Narrative

Solta medical has assessed the event according to the applicable regulatory requirements and determined this event does not meet report submission criteria.

Event Description

Additional information was received and reviewed by the medical reviewer.The nature of the injury was updated to minor burn/first degree burn on both upper and lower eyelids.The patient was treated with dacortin and enantyum, diprogenta cream, cicaplast baume b5, la roche-posay, cicabio, and photoderm.The current status is described as small scabs on the injured areas with slight erythema in the areas where the scabs were present.No lesions are present, with no permanent scar visible or expected.The case is considered non-serious and the information provided does not suggest that this incident may have caused or contributed to a death, serious injury, or a serious deterioration in state of health.Recurrence is unlikely to result in a death, serious injury or a serious deterioration in state of health.

• 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: 16689412
• MDR Text Key: 312778850
• Report Number: 3011423170-2023-00044
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Device Catalogue Number: TT0.25F6-450
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female