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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

A patient reported experiencing a burn on the cheek after a thermage facial treatment.The patient stated that there was a blister the size of a fingernail, so she went to a local professional scalding institution and was diagnosed with a burn.The doctor punctured the epidermis and pus came out.The burn was coated with growth factor and the scab was naturally removed.At the time of reporting, it was severe scarring pigmentation.The dermis is burned, not the epidermis (second degree burn).The patient declined to provide pictures.Topical anesthesia was applied thirty minutes prior to the treatment.No other treatments were performed in the same treatment area within the last 30 days.Enough coupling fluid was used for the treatment.Attempts to retrieve additional information from the patient, doctor, or clinic have been unsuccessful.The doctor that the patient reported having performed the treatment does not work in the reported institution and cannot be contacted.

Manufacturer Narrative

No additional information was able to be obtained regarding this event.The treatment tip and datalog were not provided for evaluation.It is unclear if a thermage cpt or flx treatment tip was used during this treatment.According to both thermage flx and cpt user manuals, burns are a known possible reaction to treatment.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.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.The trend analysis, risk analysis and directions for use review are considered acceptable for both products, with the products performing within anticipated rates.Due to the lack of information provided and no product being returned for evaluation, no causal factors can be determined, and no conclusions can be drawn.No corrective action is necessary at this time.

• Brand Name: THERMAGE SYSTEM AND ACCESSORIES
• Type of Device: 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: 18597967
• MDR Text Key: 334025722
• Report Number: 3011423170-2024-00118
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female