MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT4.00F6-900

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

Patient Problem Blister (4537)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested and the investigation is underway.

Event Description

A user facility reported that a patient experienced a burning blister right after the treatment on the face.The available pictures were reviewed by the medical reviewer.In the pictures taken after the treatment on the day of the procedure, inflammation, erythema and a blister are visible.In the other picture taken approximately 5 days after the procedure, crusts and hyperpigmented areas are visible on one side of the patient''s face.No other information is available regarding the current status or the outcome of the patient.The treatment energy was between 2 -3.5.

Event Description

Additional information was received.The injury is a burn to the patient''s cheek.No secondary intervention was required.There is no scarring or permanent damage.It is reported that the patient has fully recovered.Additional pictures were reviewed and two of the four pictures show inflammation while the other two photos do not show any redness or inflammation.The medical reviewer has downgraded this case to not serious.This case is no longer reportable.

Manufacturer Narrative

Additional information was received.The injury is a minor burn to the patient''s cheek.No secondary intervention was required.There is no scarring or permanent damage.It is reported that the patient has fully recovered.Additional pictures were reviewed, and two of the four pictures show inflammation while the other two photos do not show any redness or inflammation.The medical reviewer has downgraded this case to not serious.Therefore, this case is no longer subject to reportability requirements.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 16033466
• MDR Text Key: 305984918
• Report Number: 3011423170-2022-00156
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170758
• 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: 11/29/2022

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 Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2023
• 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