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

Model Number TT4.00F6-600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 08/16/2022

Event Type  Injury  

Event Description

A user facility reported that a patient experienced blisters on the cheek after a thermage treatment to the face.The exact nature of the injury was reported as blisters with pigmentation in the treatment area.An available picture of the patient's face was reviewed by the medical reviewer.Crusts and post inflammatory hyperpigmentation are visible on the side of the face on the lower part of the cheek to the mandibular area.No other treatments (besides thermage) were being performed in same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used was 3.0.No system errors occurred nor was anything out of the ordinary noticed during treatment.The treatment tip surface was inspected prior to use and nothing remarkable was noted.The treatment tip surface was inspected at about every 300 reps during the procedure.This the first time this treatment tip was used.

Manufacturer Narrative

The product has been discarded by the customer and is not available for a product evaluation.The investigation is ongoing.

Manufacturer Narrative

No other treatment or product related information was provided.According to the thermage flx user manual, blisters and hyperpigmentation are a 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.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined, and no conclusion can be drawn.No corrective action is required.

Manufacturer Narrative

Correction: b3: from (b)(6) 2021 to (b)(6) 2022.The data logs were reviewed.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.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.Based on the available information, no causal factors can be determined, and no conclusion can be drawn.

Event Description

Date of event is (b)(6) 2022.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• 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; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 15591710
• MDR Text Key: 301632714
• Report Number: 3011423170-2022-00129
• 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,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-600
• Device Catalogue Number: TT4.00F6-600
• 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: 04/08/2022
• 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