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

Model Number TTNS3.00C1-200

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested and the investigation is underway.

Event Description

A user facility reported that a patient suffered skin burning during a thermage treatment on the face.The treatment was performed on the left lower face.Frosting was seen on the skin immediately after the shot was administered.This incident occurred between 3.0-3.5.The highest energy level used was 3.5.The affected tip issued a cold warning twice.The user stopped using the tip and swapped it for a new one to complete the treatment.Solta medical cryogen and coupling fluid used during this treatment.Approximately 1 bottle of coupling fluid was used during the treatment.The treatment tip surface was said to be inspected prior to use and after the frosting occurred at 185 pulses.This is the first time the treatment tip was used.No other information is available.

Manufacturer Narrative

The assessment has been revised to not serious and is therefore no longer subject to reportability.

Event Description

Available information was received and reviewed with the medical reviewer.It was noted that a small superficial burn mark was seen and treated with a topical anti-inflammatory ointment.The current status is reported that the patient is doing well, and no permanent scar is expected.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• 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; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st louis, MO 63122 ; 6362263220
• MDR Report Key: 15392335
• MDR Text Key: 299582445
• Report Number: 3011423170-2022-00116
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K132431
• 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: 08/11/2022

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
• Device Model Number: TTNS3.00C1-200
• Device Catalogue Number: TTNS3.00C1-200
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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