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

Model Number	TT4.00F6-900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip has been requested for evaluation.The investigation is underway.
Event or Problem Description
A user facility reported small bilateral burns on the patient's cheeks after a thermage flx procedure.Available photos were assessed by the medical reviewer and crusts are visible on patient's cheeks on both sides.Though requested, no further information has been provided regarding the event.
Event or Problem Description
The user facility reported that the patient is fine, the small marks/burns disappeared a few days after the treatment, and that the event was likely due to excessive facial hairs.The user facility has not had any other incidents of the same nature with other treatments performed, all other treatments have gone well.Based on the new information, the medical reviewer concluded that this event is not a serious injury.The event no longer meets reportability requirements.
Additional Manufacturer Narrative
A medical review of this event found that no serious injuries occurred.Therefore, this event no longer meets reportability requirements.Though requested, no other treatment details were provided.The provider declined to proceed with further investigation.The treatment tip and datalogs were not returned for evaluation.A review of manufacturing records showed that all requirements were met.The trend analysis, risk analysis, and directions for use review are considered acceptable, with the product performing within anticipated rates.According to the thermage flx system user manual, burns are a known side effect of thermage flx treatments.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formations.There is a small chance of scar formation.Due to the lack of available information, no causal factors can be determined, and no conclusions can be drawn.No corrective action is necessary at this time.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Common Device Name: 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; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 20857364
• Report Number: 3011423170-2024-00233
• Device Sequence Number: 11731463
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male