MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE CPT SYSTEM TIP; 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 11/23/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested.The investigation is underway.

Event Description

A patient reported that they received a thermage treatment; after the procedure, a large area of her left face was burned, leaving her with a scar.The user facility reported a burn to the patient''s left cheek.The right face was treated with the initial energy of 3.0 - with an energy range of 3.0-3.5, no abnormalities were noted.After about 300 reps on the left face, the customer complained that the pain was more obvious than before.The doctor checked the tip, and it was obviously sunken - erythema appeared in the operation area with scattered blisters.Immediately, the patient was treated with a cold compress.After 10 minutes, the procedure continued to the forehead and the region of the jaw line, as well as the area that had erythema.The energy range was 0.5-1.5, until the end of the operation, when erythema occurred.Immediately, the patient was cooled by cold compress, smeared with mebo, and coated with growth factor gel on the affected area.The patient was administered topical anesthetics prior to the procedure.It is uncertain if there will be permanent scarring.No other treatments (besides thermage) were being performed in same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The treatment tip surface was inspected prior to use and nothing remarkable was reported.This is the first time this treatment tip was used.Available pictures were reviewed by the medical reviewer and inflammation, erythema and scattered post-inflammatory hyperpigmented areas are visible on one side of the face.

Event Description

Additional information was reviewed by the medical reviewer and this case has been re-assessed as not serious.The nature of the injury was updated to erythema accompanied with blisters on the left cheek.The patient was treated with an ice compress and applied growth factor.The outcome was reported as no permanent scar expected.

Manufacturer Narrative

This case no longer meets the criteria for reportability.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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: 16018674
• MDR Text Key: 305873618
• Report Number: 3011423170-2022-00154
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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