MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE 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); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is underway.
Event or Problem Description
It was reported that a patient experienced eye burns after a thermage treatment.The eye was red and swollen for the first two days after treatment, then scabbed and was painful.An eye shield was used during the thermage treatment.Solta medical cryogen and coupling fluid were used for the treatment.After the burn was observed, the patient was provided with cold compresses and ointments.It is unclear if a thermage flx or thermage cpt device was used.Though requested, no additional information has been provided.
Additional Manufacturer Narrative
The treatment tip was not returned for evaluation, nor were the datalogs submitted for review.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.As the product serial number was not provided, a review of the device history record cannot be performed and it is still unclear if this was a thermage cpt or thermage flx treatment.According to the thermage cpt and the thermage flx user manual, blisters and redness are known possible side effects during thermage treatments.The procedure produces heating in the upper layers of the skin, and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.According to the thermage safety risk assessments, corneal abrasions are possible hazards of treatment.Solta medical provides safety considerations in the thermage user manuals when treating the eyelids.Users must follow procedural instructions, so the treatment is performed in a safe manner.Solta medical emphasizes that only plastic ocular shields with proper sizing must be used during thermage treatment, in order to prevent serious eye injury from the thermal effects of the radiofrequency (rf) energy used by the system.Although metallic ocular shields may be appropriate to use with certain laser treatments of the eyelids, they are not appropriate for use with thermage as metallic ocular shields will conduct the thermal energy from thermage¿s radiofrequency (rf) energy directly to the eye, causing damage.Eye shields are not provided by solta medical.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Though requested, no additional information has been provided and the product/datalogs have not been returned for evaluation.Based on the available information, no causal factors can be determined and no conclusions can be found.No corrective action is necessary at this time.

• Brand Name: THERMAGE 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: 18742988
• Report Number: 3011423170-2024-00126
• Device Sequence Number: 6380276
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female