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 Sparking (2595)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537); Localized Skin Lesion (4542)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

The data log and treatment tip were returned for evaluation.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip was evaluated and there was no evidence of any sparking.The tip passed thermistor testing, leak testing, and visual inspection.No dents, scratches, blemishes, or dielectric breakdown was observed.No functional testing could be performed due to the tip being expired.According to thermage flx user manual, burns and blisters are a known possible side effects during a 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.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record for the serial/lot number.Based on the available information, burns and blisters are a known possible side effects during a thermage flx treatment.No corrective action is necessary at this time.

Event Description

A user facility reported that they had performed a facial thermage treatment and saw a spark from the tip.It was then reported the patient received a burn on the left side of their forehead which blistered.The customer later described the injury as a lesion with erythema.Solta medical branded cryogen and 25%-50% bottle of coupling fluid was used with the highest level of treatment at 2.0.The customer performed treatment on the right side of the patient¿s forehead with no problems, and no system errors had occurred during the procedure.This was the initial use of the treatment tip.The treatment tip was inspected prior to use, and every 120 pulses with no discrepancies found.Around 120 reps were performed, and the issue occurred around rep 50 on the second part of the forehead.After the procedure, it was observed the patient had a lesion with erythema on the left side of their forehead.The customer cleaned the area with a wet wipe, applied an ice pack and vaseline, before wrapping the area with a bandage.The patient¿s current status is that they are not feeling any pain however the injury area has darkened.Three pictures of the patient's face were reviewed by the solta medical reviewer.It was observed in the first picture, there was a small wound with surrounding erythema immediately following the procedure.A second photo showed a darkened area with surrounding erythema taken 5 minutes after the first picture.The third picture, taken 24 hours after the treatment, showed a crusted area with surrounding hyperpigmentation.A picture taken a month following the procedure shows hyperpigmentation on the forehead.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17312865
• MDR Text Key: 319018324
• Report Number: 3011423170-2023-00067
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2023

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: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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