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

Model Number TT4.00F6-900

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.As the treatment tip serial number was not provided by the reporter, review of the device history record cannot be performed.According to the thermage flx user manual, burns are a known possible side effect 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.It was reported the patient was placed under anesthesia during treatment.Anesthetizing a patient during flx treatment is considered off label use.Patient feedback is essential input to guide the user in determining safe and effective treatment levels.The user manual also instructs operators on correcting applying the return pad to so proper connect is made.Incorrect placement and poor contact of the return pad may result in patient burns, and/or system performance issues.The return pad should be attached to a location for return pad that is a well-vascularized area and has minimal curvature, for example, the lower back area, or side (just above the hip) that is free of hair, free of tattoos, and completely dry.The return pad should never be applied to the shoulder, neck, head region, legs or arms.The return pad was placed on the back of the neck where the burn occurred.Incorrect placement and poor contact of the return pad may result in patient burns.Based on the available information, this treatment was performed in an unsafe an unapproved or off-label manner both with respect to anesthetizing the patient and to placing the return pad on the patient¿s neck.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Trending will be performed to monitor this issue.No corrective action is necessary at this time.

Event Description

A user facility in korea reported that a patient experienced a neck burn after a thermage flx facial treatment.The patient received a treatment in the afternoon with 600 shots under sleep anesthesia at an energy level of 3.0.There were no error messages during the procedure and no problem was observed immediately afterward, but the patient discovered a burn to the back of the neck after returning home.The exact location of the injury is the back of the neck where the thermage return pad is applied.No secondary intervention was no other treatments were performed in the same symptom area within the past 30 days.The tip had not been used before and was not inspected prior to use, but was inspected every 100 pulses during treatment.The treatment tip was not retained for evaluation.Solta medical cryogen and coupling fluid (60ml) were used during this treatment.A medical review of the provided picture noted that blisters and erythema are visible on the back of the neck.As the patient has not visited the clinic after the thermage treatment, the patient¿s current status and the type(s) of treatment, if any, are unknown.It is unknown if there will be permanent damage or scarring.

Manufacturer Narrative

An update was received indicating that the patient has been treated for burns at the hospital and has improved significantly.The treatment tip was not available for evaluation.Evaluation of the system logs has been completed, and showed that a high temperature error occurred during the treatment.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.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 handpiece and system performed as expected.It is recommended that the user verifies proper treatment technique, position, and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).The handpiece should be perpendicular to the ground at the time of the treatment.The review of the system/data logs does not indicate there is any handpiece or system issue present.The device history record has been reviewed now that the serial number is known.Final test verification specifications are acceptable.No non-conformities or anomalies were found related to this event when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The conclusions of the initial report remain unchanged.No corrective action is necessary at this time.

Event Description

An update was received indicating that the patient has been treated for burns at the hospital and has improved significantly.

• Brand Name: THERMAGE FLX (TG-3A) AND ACCESSORIES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17127597
• MDR Text Key: 317215651
• Report Number: 3011423170-2023-00060
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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