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 Insufficient Information (3190)

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

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Treatment tip was returned and evaluated and no issues were found.Tip passed visual inspection, leak test, and thermistor test.Functional test was not performed due to the tip being expired.The review of the system/data logs does not indicate there was any handpiece or system issue present.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A clinic reported that during a thermage treatment a patient suffered burns on the face at around 370 reps.Available pictures were reviewed.On one side of the face a scar lesion with erythema and inflammation is visible.On the other side of the face, blisters are healing and no scar was observed.Erythema is not visible on the forehead.The current patient status and the outcome is unknown at this time.It was reported that system and handpiece cryogen fluid was flowing without issues.Tip too warms errors were reported.The tip was inspected before and during the treatment at every 100 reps and no issues were noted.Enough coupling fluid was used.The highest energy used was 3.5.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.The treatment tip and datacard logs were returned for evaluation.No issues were found during the evaluation of the treatment tip.The datacard logs were reviewed and the evaluation of the data found the system and handpiece performed as expected.The datacard log confirmed the customer¿s account of tip too warm error occurring during treatment.If a treatment tip¿s thermistors exceed the maximum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a ¿tip too warm¿ error and place the system into a safe state.This condition presents no patient risk.Based on the available information, burns are a known possible side effect 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 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman street north; rochester, NY 14609
• MDR Report Key: 13476400
• MDR Text Key: 286009728
• Report Number: 3011423170-2022-00007
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

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: TT4.00F6-600
• Device Catalogue Number: TT4.00F6-600
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male