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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 05/23/2021

Event Type  Injury  

Event Description

A user facility reported a burn with blisters and a sunken wound to the side of the nose by the upper smile line one day post thermage flx treatment.The patient was given 1 tablet paracetamol, 20mins before the thermage treatment.For the reported injury, the patient was told to apply aloe vera gel.The patient''s status, at the time of this event , was reported as pigmentation which may result in a "little pigmentation".At that time, available photos were reviewed by the medical reviewer which revealed blisters next to patient''s nose.This case was assessed as not serious.Additional information was recently received for the patient outcome.It was reported that the patient has recovered without any permanent injury.However, it is noted that the recovery process took approximately two years of treatment including receiving multiple prp treatments done by a plastic surgeon.The nature of the injury was recently reported by the physician and noted as first degree burn which affected both the dermal and epidermal layers.Due to this recent additional information, the status of the reportability assessment has been revised to serious.No other treatments (besides thermage) were being performed in the same area where symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within the past 30 days.This incident is reported to have occurred at 900 reps for face and neck.The highest energy level used was 3 for face and 2 for jaw.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 user reported that enough coupling fluid was applied on the patient''s face.The treatment tip surface was inspected prior to use and this is the first time the treatment tip had been used.

Manufacturer Narrative

The data logs were reviewed and based on the evaluation of data, the system and the handpiece performed as expected.Even though the handpiece''s clip had been damaged, it was still electrically integrity connected.Error codes from the logs indicated the following user errors occurred: quantity: (b4); error id - ec785; description- err_treatment_tip_lifted_prematurely; percent of reps - 1.78%.Quantity: (b)(4); error id - ec78b; description- err_treatment_tip_force_low; percent of reps - 0.22%.Quantity: (b)(4); error id - ed4c2; description- err_gen_tuning_failure; percent of reps - 0.11%.Quantity: (b)(4); error id - ec786; description- err_treatment_tip_rep_count_limit_reached;percent of reps - 0.11%.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, users are directed to follow the instructions on the touchscreen to proceed.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.Based on the evaluation of data the system and the hand-piece performed as expected.The review of the system/data logs did not indicate there is any hand-piece or system issue present.The thermage treatment tip was returned and evaluated.The tip passed the leak test and thermistor test.The tip passed visual inspection as no dents, scratches, blemishes, or dielectric breakdown was observed.No functional test was performed due to tip being expired.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.According to thermage flx system user manual, burns and blisters are known possible adverse patient reactions to 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.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.The lot/device history review and trend analysis were considered acceptable, and the product is performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.No corrective action is necessary at this time.

• 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: 18057174
• MDR Text Key: 327196723
• Report Number: 3011423170-2023-00089
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1