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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/02/2021

Event Type  Injury  

Manufacturer Narrative

Data-log of the treatment was evaluated.Evaluation of the data suggests that the handpiece and system performed as expected.Treatment tip has been requested for evaluation, but not yet received.A review of the device manufacturing record has been initiated but not yet completed.Based on currently available information no conclusion can be drawn and no cause has been established.

Event Description

The patient reported by phone that they experienced blistering on both eyes following a thermage flx eye treatment.The treatment details were collected from the treating clinic upon follow up.The doctor reported that prior to treatment they inspected the treatment tip with no observed abnormalities and the patient was administered an unknown topical anesthetic.The doctor reported the treatment was completed without any issue, ample coupling fluid was used, and the highest energy level was 2.5.The patient reported noticing blisters forming on the left eye lid immediately following treatment.The patient used cold compress over the eyes.The following day the patient noticed less severe blistering on the right eye as well and visited the local hospital for diagnosis.Patient was diagnosed with burn and prescribed an unidentified scald cream.Available pictures were reviewed by medical evaluator.Two small crusts are visible on the upper eyelid and two small post inflammatory hyperpigmented lesions are visible on the lower eyelid.Current patient status was reported as slight hyperpigmentation remaining.

Manufacturer Narrative

Treatment tip was returned to manufacturer and evaluated by technical team.The tip passed leak and thermistor testing, as well as visual inspection, with no observed abnormalities.No functional testing was performed due to the tip being expired.A review of the treatment data was previously completed, and showed the system and handpiece performed as expected during treatment.A review of the device manufacturing record has been initiated but not yet completed.Based on currently available information no conclusion can be drawn and no cause has been established.

Manufacturer Narrative

According to thermage flx system user manual burns are a known possible adverse patient reaction 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.A review of the manufacturing records showed all requirements were met.Data logs confirmed the system and handpiece performed as expected.Evaluation of the treatment tip found no issues related to this event.This event is most likely unrelated to the device.Based on the available information, burns and blisters are a known possible side effects during thermage flx treatment.

• 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 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 12760906
• MDR Text Key: 280474485
• Report Number: 3011423170-2021-00124
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 11/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 03/11/2022
• Supplement Dates FDA Received: 12/16/2021; 04/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male