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); Blister (4537); Swelling/ Edema (4577)

Event Date 08/16/2022

Event Type  Injury  

Event Description

A user facility reported that a patient experienced small burn/blister(s) like spots on both of her cheeks following a thermage flx treatment.It was reported that the patient had received a facial two days prior to the procedure; however, they did not disclose what kind of facial.No further information on the patient is available.There were no error codes during the procedure.

Manufacturer Narrative

The device has been requested to be returned; however, it has not been received for an evaluation.The plant evaluation is underway.

Manufacturer Narrative

The datacard log was returned for an evaluation.The datacard logs showed the errors occurred during two treatments from the date of event.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.

Manufacturer Narrative

No other treatment information was provided.The product has not been returned for evaluation; however, the product has been requested to be returned.Should the product be returned, a follow up will be submitted.According to thermage flx system user manual, burns are a known possible adverse patient reaction to the thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formation.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Due to the lack of information provided, no causal factors can be determined and no conclusions can be drawn.No corrective action is required.

Manufacturer Narrative

The thermage flx tip was returned and evaluated.Evaluation of the treatment tip found one corner of the tip was not glued like the other 3 corners exposing an opening in the tip membrane.Service was unable to verify tip functionality as the tip is expired and all reps have been spent.The tip failed the leak test.The tip could not pass visual inspection as there is missing glue in one corner.No dielectric breakdown was observed.The tip passed the thermistor test.No functional test was able to be performed due to tip being expired.This damage of the membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area resulting in first degree patient burns.User manual instruct user to observe condition of tip during treatment.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, burns were most likely caused by the absence of glue on the tip corner.It is unknown how the edge of the tip became damaged or reportedly unglued.The user will want to make sure to use a new tip every treatment.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; 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: 15439868
• MDR Text Key: 300069989
• Report Number: 3011423170-2022-00120
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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
• Patient Sex: Female