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 Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/04/2023

Event Type  Injury  

Manufacturer Narrative

The data logs were reviewed by service and based on the evaluation of the data, the handpiece performed as expected; however, the system did not perform as expected due to errors that occurred throughout the treatment.The customer will need to verify that enough coupling fluid was used and that the return pad placement and connection are correct.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.The datacard log confirmed the customer¿s account of return pad errors that occurred during treatment.These errors did not persist.This condition presents no patient risk.The tip was returned and evaluated.The tip passed the leak test and visual inspection.The tip also passed the thermistor test.No functional test was able to be performed due to tip being expired.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 directions for use review were considered acceptable, with the product performing within anticipated rates.No issues found related to this event during evaluation.According to thermage flx safety risk assessment, urticaria and similar reactions to welts are known possible reactions to treatment.Based on the available information, this event is a known possible reaction to treatment.No corrective action is necessary at this time.

Event Description

A user facility reported welts the night after a thermage flx procedure to the patient''s abdomen.The customer also reported return pad error codes.Secondary intervention (ointments, medications, etc.) required to treat this event included prescription strength steroid cream with neosporin applied twice a day.A sheet mask was done to the area as well.It is reported that the patient still has welts.Due to the patient''s skin type, it is likely they will have hyperpigmentation.Available picture was reviewed by the medical reviewer and multiple crusts and hyperpigmented areas are visible on patient''s abdomen.The patient was not administered any pain medication or placed under anesthesia.Solta medical cryogen and 1/2 bottle of coupling fluid used during this treatment.The treatment tip surface was inspected prior to use and mulitple times during use and there was nothing remarkable.This was the first time the treatment tip was used.No other treatments (besides the one reported) were being performed in the same area where symptoms were reported.This event occurred in the 500 rep range and the highest energy level used was a 1.The patient has not undergone any other treatments in the same symptom area within the past 90 days.The patient has had prior aesthetic treatments on this area, lidocaine 10% cream x 30 min.

• 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; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17050192
• MDR Text Key: 316467589
• Report Number: 3011423170-2023-00055
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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