THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
Report
- Report Number
- 3011423170-2022-00013
- Event Type
- Injury
- Date Received
- February 17, 2022
- Date of Event
- January 18, 2022
- Report Date
- January 18, 2022
- Manufacturer
- SOLTA MEDICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K132431
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE TREATMENT TIP HAS BEEN REQUESTED BUT NOT YET RETURNED FOR EVALUATION. BASED ON THE CURRENTLY AVAILABLE INFORMATION NO CONCLUSION CAN BE DRAWN AND NO CAUSE HAS BEEN ESTABLISHED.
THE TREATMENT TIP HAS BEEN REQUESTED BUT NOT YET RETURNED FOR EVALUATION. BASED ON THE CURRENTLY AVAILABLE INFORMATION NO CONCLUSION CAN BE DRAWN AND NO CAUSE HAS BEEN ESTABLISHED.
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. NO CORRECTIVE ACTION REQUIRED. DATA-LOGS CONFIRMED THE SYSTEM AND HANDPIECE PERFORM AS EXPECTED. EVALUATION OF THE TREATMENT TIP FOUND NO ISSUES. IT WAS REPORTED THE PATIENT WAS PLACED UNDER SLEEP ANESTHESIA. THE PATIENT SHOULD NEVER BE PLACED UNDER ANESTHETICS DURING THERMAGE FLX TREATMENT. THE PATIENT MUST BE ALERT AND PROVIDE REQUIRED FEEDBACK DURING TREATMENT. PATIENT FEEDBACK REGARDING THEIR PERCEPTION OF HEAT OR DISCOMFORT DURING THE PROCEDURE IS AN ESSENTIAL INPUT TO GUIDE THE OPERATOR IN DETERMINING SAFE AND EFFECTIVE TREATMENT LEVELS. BASED ON THE AVAILABLE INFORMATION, THIS TREATMENT WAS PERFORMED IN AN OFF-LABEL MANNER THAT RESULTED IN UNSAFE CONDITIONS FOR THE PATIENT.
THE TREATMENT TIP WAS RETURNED AND EVALUATED. THE TIP PASSED LEAK AND THERMISTOR TESTING. VISUAL INSPECTION OF THE TIP WAS COMPLETED AND NO DEFECTS WERE NOTED. FUNCTIONAL TESTING WAS NOT POSSIBLE DUE TO THE CONDITION OF THE RETURNED DEVICE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS IS UNDERWAY. BASED ON AVAILABLE INFORMATION NO CONCLUSION CAN BE DRAWN AND NO CAUSE IS ESTABLISHED.
A DOCTOR REPORTED THAT THEIR PATIENT EXPERIENCED SEVERAL PATCHES OF ERYTHEMA AND BLISTERING ON THE RIGHT SIDE OF THEIR FACE AND NECK FOLLOWING A THERMAGE FLX TREATMENT. THE DOCTOR INDICATED THAT THE TREATMENT WAS COMPLETED AT A MAXIMUM POWER LEVEL OF 5.5, USING 20-30ML OF SOLTA CRYOGEN COUPLING FLUID, AND THAT THE TREATMENT TIP WAS INSPECTED BOTH PRIOR TO USE AND EVERY 10 PULSES WITH NO ABNORMALITIES REPORTED. SEVERAL ERROR CODES WERE NOTED DURING THE TREATMENT. THE PATIENT WAS TREATED WITH AN UNKNOWN INTRAVENOUS ANESTHETIC PRIOR TO TREATMENT. FOLLOWING TREATMENT, THE DOCTOR OBSERVED THAT THE PATIENT EXPERIENCED SEVERAL SPOT-LIKE REDNESS AND BLISTERS ON THE CHEEK AND NECK AREA OF THE RIGHT SIDE THEIR FACE. THE PATIENT WAS TREATED WITH DUODERM AND HQB THERAPY FOR SCAR PREVENTION. THE PATIENT CURRENTLY HAS BLISTERS THAT ARE NOT RESOLVING WITH POSSIBILITY OF PERMANENT SCARRING. AVAILABLE PICTURES WERE REVIEWED. IN THE PICTURES TAKEN IMMEDIATELY FOLLOWING THE PROCEDURE INFLAMMATION AND BLISTERS ARE VISIBLE ON THE RIGHT SIDE OF THE FACE AND NECK. THE FOLLOW UP PICTURES SHOW LARGE BLISTERS REMAIN ON THE RIGHT SIDE OF THE FACE, CHEEK AND NECK AREA.
A DOCTOR REPORTED THAT THEIR PATIENT EXPERIENCED SEVERAL PATCHES OF ERYTHEMA AND BLISTERING ON THE RIGHT SIDE OF THEIR FACE AND NECK FOLLOWING A THERMAGE FLX TREATMENT. THE DOCTOR INDICATED THAT THE TREATMENT WAS COMPLETED AT A MAXIMUM POWER LEVEL OF 5.5, USING 20-30ML OF SOLTA CRYOGEN COUPLING FLUID, AND THAT THE TREATMENT TIP WAS INSPECTED BOTH PRIOR TO USE AND EVERY 10 PULSES WITH NO ABNORMALITIES REPORTED. SEVERAL ERROR CODES WERE NOTED DURING THE TREATMENT. THE PATIENT WAS TREATED WITH AN UNKNOWN INTRAVENOUS ANESTHETIC PRIOR TO TREATMENT. FOLLOWING TREATMENT, THE DOCTOR OBSERVED THAT THE PATIENT EXPERIENCED SEVERAL SPOT-LIKE REDNESS AND BLISTERS ON THE CHEEK AND NECK AREA OF THE RIGHT SIDE THEIR FACE. THE PATIENT WAS TREATED WITH DUODERM AND HQB THERAPY FOR SCAR PREVENTION. THE PATIENT CURRENTLY HAS BLISTERS THAT ARE NOT RESOLVING WITH POSSIBILITY OF PERMANENT SCARRING. AVAILABLE PICTURES WERE REVIEWED. IN THE PICTURES TAKEN IMMEDIATELY FOLLOWING THE PROCEDURE INFLAMMATION AND BLISTERS ARE VISIBLE ON THE RIGHT SIDE OF THE FACE AND NECK. THE FOLLOW UP PICTURES SHOW LARGE BLISTERS REMAIN ON THE RIGHT SIDE OF THE FACE, CHEEK AND NECK AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1917411 | THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES | ELECTROSURGICAL,CUTTING & COAGULATION & ACC. | GEI | SOLTA MEDICAL INC. | TT3.00F6-1200 | 222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |