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

Model Number TH-6R

Device Problems Excessive Cooling (2932); Excessive Heating (4030)

Patient Problem Blister (4537)

Event Date 10/05/2023

Event Type  Injury  

Event Description

A user facility reported blisters on the patient''s chin and neck subsequent to a thermage flx treatment on the face and neck.The available picture was reviewed by the medical reviewer who noted that crusts are visible on patient''s chin and neck.The patient was not administered any pain medication or placed under anesthesia during the treatment.Upon observation of the blisters, the patient was treated with mupirocin antibiotic ointment, biocream, and aquaphor.The patient's current status is reported to be "healing nicely".The provider is unable to determine if there will there be any permanent damage or scarring at this time.No other treatments (besides the one reported) were being performed in same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days, nor had the patient had prior aesthetic treatments on this area.The incident occurred at about 440 reps with the highest energy level used as a 3."tip too warm" and "tip too cold" errors occurred, as well as frosting on the treatment tip.Solta medical cryogen and a normal amount of coupling fluid were used during this treatment.This treatment was the initial use of the treatment tip, which was inspected prior to use with nothing unusual to note.The treatment tip surface was occasionally reinspected during the treatment.The treatment tip was not retained for evaluation.

Manufacturer Narrative

The data logs were reviewed and based on the evaluation of the data, the system performed as expected; however, the handpiece did not perform as expected.The data is suggestive for a suspected cryogen leak.The handpiece was returned for evaluation.A supplemental report will be filed when the results of the handpiece are available.The investigation is ongoing.

Manufacturer Narrative

Information regarding patient outcome notes that the blister was resolved.As such, this event no longer meets reportability requirements.

Event Description

Information regarding patient outcome notes that the blister was resolved.As such, this event 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 north 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: 18055698
• MDR Text Key: 327166166
• Report Number: 3011423170-2023-00088
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

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: TH-6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1