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 11/28/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested.The investigation is underway.

Event Description

A user facility reported that a patient experienced blisters post procedure.The report noted that the blisters occurred approximately two days afterwards.No treatment or the outcome was reported.Available pictures were reviewed by the medical reviewer.The pictures that were taken on the treatment day, show only erythema.The pictures taken the evening of the procedure day, show blisters on both cheeks.Pictures marked as today (probably nov.30) show the blisters are recovering.Mild hyperpigmentation is also visible.The energy used was between 2-3.No other information was provided.

Event Description

Additional information was received.The injury was reported as a burn/blister 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.An additional picture was reviewed, and no blister is visible.Hyperpigmented lesions was visible on one cheek.The medical reviewer has downgraded this case to not serious.

Manufacturer Narrative

This case was initially reported with limited information.Additional information was received.The injury was reported as a blister 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.An additional picture was reviewed and no blister is visible.Hyperpigmented lesions were visible on one cheek.The medical reviewer has downgraded this case to not serious.Therefore, this case no longer meets 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: 16033440
• MDR Text Key: 305983421
• Report Number: 3011423170-2022-00155
• 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

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Is the Reporter a Health Professional?: No
• 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