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

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

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

A user facility reported a burn to a patient''s face immediately after a thermage cpt treatment.After the treatment, the patient''s face immediately had blisters, and was given a cold compresses and smeared ointment.The next day, the patient reported that there were more blisters, seven or eight big blisters.At the end of the treatment, the doctor gave the patient the burn cream and spray and let the patient go home to apply the mask.Two days later, the face condition was more severe.The tissue fluid had been oozing.Then the patient went to the hospital for inspection of injuries and was diagnosed with secondary burns.The hospital said that the medicine given by the clinic was wrong, and medicine was re-prescribed (the name of the specific drug is unknown).The patient states that this incident has delayed her work and daily life.Now her face cannot be exposed to the sun and cannot wear a mask.The treatment tip was not kept for an evaluation.No other information has been provided.This case will be updated as more information is received.

Manufacturer Narrative

The product and datalogs were not available for an evaluation.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of the acceptable limits.According to thermage cpt system technical user¿s manual, burns are a known possible patient reaction to thermage 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 were considered acceptable, with the product performing within anticipated rates.As no product serial number was provided, a manufacturing record review was unable to be performed.It is unclear if this is a true solta device, as the clinic is not a customer of solta or our distributor.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is necessary.

Event Description

The solta distributor reported that they did not sell a thermage device to the clinic that was reported.The clinic is also not a client of the distributor.It is unknown if the device used for this procedure was a solta made thermage device or a counterfeit.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: 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; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18172885
• MDR Text Key: 328560622
• Report Number: 3011423170-2023-00093
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2024
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1