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 Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 04/04/2022

Event Type  Injury  

Event Description

A distributor reported that a user facility performed a thermage treatment on a patient and after completion of the treatment, blisters were found on both the right side and left side of the patient's face.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 3.5.The patient was treated on the right side of their face and at 80 pulses, the system showed event code and displayed a tip too warm message.The treatment was stopped for a moment and then resumed with no additional errors.After resuming treatment an electric sound was heard, and erythema on the patient was observed.The patient was given a cold compress and burn ointment immediately, and the erythema subsided.The treatment tip was inspected prior to the procedure and it was noted the tip surface looked irregular.The tip was inspected again when the electric noise occurred, its unknown if any other problems were found at that time.The blisters had reportedly gotten worse the next day.The patient did not receive any other treatment on the same day or within 30 days prior, in the symptom area.Pictures of the patient were reviewed and there were blisters on the patient's cheek, however it was not clear if the injury was on both cheeks.The current status is reported as hyperpigmented and hypopigmented lesions with an unknown outcome.

Manufacturer Narrative

The data logs and treatment tip have been requested to be returned to the manufacturer but have not yet been received.A plant evaluation is underway.

Manufacturer Narrative

The data log from the patient event has been reviewed and it showed an error code had occurred.When the system detects a condition that interrupts treatment, a system error code is displayed.The system provides an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece performed as expected the tip was returned for evaluation.Service was unable to verify reported complaint due to tip being expired.The tip passed the leak test, and passed the visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.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 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.

• 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; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 14523538
• MDR Text Key: 292827355
• Report Number: 3011423170-2022-00069
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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
• Treatment: UNKNOWN TOPICAL ANESTHETIC
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female