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

Model Number TTNS3.00E4-900

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

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for an evaluation.The investigation is underway.

Event Description

A user facility reported that a patient suffered a burn to the back of the waist where the location of the return pad was placed for a thermage cpt treatment to the face.No adverse event was reported or witnessed during the procedure.After the treatment, the patient returned home and contacted the clinic and informed them that there was a burn on the back of the waist where the return pad was placed.The patient then went to the emergency room for treatment, but the exact treatment that the patient had is unknown.However, it is reported that the patient was not hospitalized.Furthermore, since the patient lives far from the clinic, the patient decided taking the follow up treatment to another clinic.No further information is available regarding the patient outcome.An available photograph of the patient was sent in and reviewed by the medical reviewer.A crusted wound is visible with blisters surrounding the crust on one side of the back.On the other side of the back, erythema and small blisters are visible.No other treatments (besides thermage) were being performed in same area where the symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within the past 30 days.It is reported that the event occurred after 900 reps and that the highest energy used was 2.5.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta medical croygen and 30 ml of coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and there was nothing remarkable.The treatment tip surface was also inspected at about every 100 reps.This is the first time the treatment tip was used.The treatment tip was discarded and unavailable for an evaluation.The procedure was performed under general anesthesia (sleep anesthesia).

Manufacturer Narrative

The field service engineer attempted to visit the hospital to perform system checks and download the log files regarding this issue.However, the treated patient and user declined the visit, as they do not wish for their personal information or the details of this issue to be disclosed.Due to the customer''s refusal to provide log data and the utilized tips, further updates to this case are not possible.According to thermage cpt user manual, burns are a known possible side effect during thermage cpt treatment.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.The user manual also instructs operators on correctly applying the return pad so proper connect is made.Incorrect placement and poor contact of the return pad may result in patient burns, and/or system performance issues.The return pad should be attached to a location that is a well-vascularized area and has minimal curvature, for example, the lower back area, or side (just above the hip) that is free of hair, free of tattoos, and completely dry.The return pad should never be applied to the shoulder, neck, head region, legs or arms.At the time of this investigation, there were no reports of any system errors or issues.It was reported the patient was placed under anesthesia during treatment.Anesthetizing a patient during a cpt treatment is considered off label use.Patient feedback is essential input to guide the user in determining safe and effective treatment levels.The return pad was placed on the wrist where the burn occurred.The return pad should never be applied to the shoulder, neck, head region, legs or arms.Incorrect placement and poor contact of the return pad may result in patient burns.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this treatment was performed in an unsafe an unapproved or off-label manner.No corrective action is necessary at this time.

• 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: 17305933
• MDR Text Key: 319012295
• Report Number: 3011423170-2023-00066
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention