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 Noise, Audible (3273)

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

Event Date 04/24/2022

Event Type  Injury  

Event Description

A distributor reported that a user facility had performed a thermage eye treatment on a patient and the patient received a burn.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 2.5.The patient received 110 pulses on their left eye with no issues.When the right eye was treated with about 50 pulses, an electric noise was heard, and erythema and edema was observed on the right eyelid.The patient was immediately given a cold compress and burn ointment.The treatment tip was inspected with no issues found and then the procedure continued at a lower treatment level.The tip was evaluated prior to the procedure and after every 20 pulses with no discrepancies.The day after treatment the patient¿s eyelids looked dull and red with blisters.The patient had not received any other treatment on the procedure day or within 30 days prior, in the same symptom area.Pictures of the patient were reviewed, and it showed scabs and erythema on one eyelid and the other was erythematous.The current status and patient outcome is unknown.

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 and tip were returned and evaluated.Service was unable to verify reported complaint due to the tip being expired.The tip passed leak testing, thermistor testing, and visual inspection.No dents, scratches, blemishes or dielectric breakdown (db) was observed.The data log from the patient event was reviewed and it showed a system error had occurred during treatment.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, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece perform as expected.A review of the manufacturing records showed all requirements were met.There were no non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number.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 is required.Based on the available information, burns are known possible adverse patient reactions to thermage flx treatment.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: 14523262
• MDR Text Key: 292817182
• Report Number: 3011423170-2022-00068
• 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 Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Device Catalogue Number: TT0.25F6-450
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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 AESTHETICS
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female