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 Problems Burn(s) (1757); Blister (4537)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested.Further investigation is underway.

Event Description

A user facility reported burns and blisters to the patient''s neck 1-day post thermage flx treatment.The area of the body that was treated was the face and neck.No other treatments were being performed in the same area where symptoms were reported.The highest energy level used was2 kj.No other system errors occurred, nor was anything out of the ordinary noticed during treatment.It is noted that enough solta medical cryogen and 30ml of coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and during treatment at about every 10 reps without anything remarkable reported.This the first time this treatment tip was used.The patient outcome has been requested.

Manufacturer Narrative

At the time of this report, no product has been returned for an evaluation.If the product should happen to be returned, a supplemental report will be filed.According to thermage flx user manual, burns and blisters are known possible side effects 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.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and 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 conclusions can be drawn.No corrective action is necessary at this time.

Event Description

The patient has recovered from the injury with no permanent damage or scarring.The medical reviewer has reassessed the file and with the new information has deemed the event not serious.As such, the event no longer meets reportability requirements.

Manufacturer Narrative

This event no longer meets reportability requirements.The investigation and conclusions from our initial assessment remain unchanged.

• 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 n 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: 17606383
• MDR Text Key: 321776574
• Report Number: 3011423170-2023-00075
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-600
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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