MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE CPT SYSTEM AND ACCESSORIES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537); Conjunctival Hemorrhage (4808)
Date of Event	04/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The treatment was conducted normally, and no equipment malfunctions were reported.The patient has reportedly fully recovered.The event remains classified as serious by the solta medical reviewer due to the patient's need for ophthalmologic evaluation by a second physician, which is outside standard of care.
Additional Manufacturer Narrative
The treatment tip and datalogs were not returned for evaluation.The device information has not been provided.According to the thermage cpt system user manual, redness, discomfort, and blisters are known possible adverse patient reactions to thermage cpt treatment.Erythema/blanching may occur in mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer (up to several weeks).Blanching usually resolves within twenty-four (24) hours.Typically, the discomfort is temporary during the procedure and localized within the treatment area.Rarely, patients have reported transient aching in the treatment area lasting up to several months.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.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.
Additional Manufacturer Narrative
The investigation is underway.
Event or Problem Description
It was reported that a patient¿s right upper eyelid was red and painful post a thermage cpt treatment.The patient¿s eye blistered shortly after the treatment.The doctor told the patient to keep the area dry.No treatment was prescribed at this time.Three days later, the patient reported having several scabs on the right upper and lower eyelids and pain in the eyes.An ophthalmological examination at an external hospital diagnosed conjunctival hemorrhage in the right eye.The patient was treated with external application of recombinant human epidermal growth factor solution, keeping the wound dry, and reexamination after the scab fell off.Though requested, no additional information has been provided.

• Brand Name: THERMAGE CPT SYSTEM AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• 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: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 20795858
• Report Number: 3011423170-2024-00229
• Device Sequence Number: 12733313
• Product Code: GEI
• UDI-Device Identifier: 00850608002445
• UDI-Public: 00850608002445
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173759
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown