MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE CPT SYSTEM TIP; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TTNS3.00E4-1200
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter refused to provide any further information.Attempts are being made to gather more event information, name of clinic and device used in the treatment.
Event or Problem Description
A patient reported experiencing burns on her face and neck from an unknown (cpt or flx) thermage treatment to the face and neck.Some of the burns have been reportedly classified as second degree and bedsores.Her husband, acting as her attorney, has stated that there will be no further information provided.They declined to provide event information, the specific device used, and the name of the clinic.
Additional Manufacturer Narrative
Additional information was received on june 24, 2024 and it was found the user facility also reported this issue on march 18, 2024 as reported on report number: (b)(4) ; 3011423170-2024-00142.The device was returned and evaluated on manufacturer's reference number: (b)(4).3011423170-2024-00142.The conclusions from the previous report submission manufacturer's reference number remains unchanged.The conclusions from the previous report submission (3011423170-2024-00142) remains unchanged.
Event or Problem Description
Additional information was received, and it was found the facility also reported this issue prior to reporting on report number: 3011423170-2024-00142.Additional information was received on june 24, 2024 and it was found the user facility also reported this issue on march 18, 2024 as reported on report number: 3011423170-2024-00142 this filing is a retraction since this event was submitted under report number: 3011423170-2024-00142.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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 north 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: 19384899
• Report Number: 3011423170-2024-00163
• Device Sequence Number: 19851575
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female