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

Model Number TTNS3.00E4-1200

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

The reporter confirmed that prior to the treatment as well as during the treatment, the tip was inspected and nothing was noted on the surface.The tip was returned and evaluated.The tip passed flow and thermistor testing, however, failed leak and visual testing.A tear was noted on the tip.In addition, no functional testing was performed as no reps remained on the tip.A review of the device history log is currently in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that a patient received a laser treatment on their face and jawline and experienced erythema, inflammation and blisters.A moderate amount of redness was noted on the right side immediately after being treated and ice gel pads were applied.Two red and well defined blisters, approximate 2-3 millimeters in diameter, were noted on the right cheek while multiple surface irregularities were noted around the patient's jawline.The patient stated that discomfort was experienced throughout the treatment.The discomfort was described as moderate to severe on both temples and the jawline.Post-treatment, the patient stated that their cheeks hurt like they a had a sunburn.Prescribed medication included an unknown antibiotic ointment.Post-procedure images were reviewed and erythema, inflammation and blisters are visible on the right cheek.The patient's current status was reported as feeling good, no pain, however, there are multiple areas of hyper-pigmentation on the right cheek.The highest energy level used was 3.0.The doctor noted that a different sound was being emitted every 20-30 pulses for the last 300 pulses.The tip was inspected before treatment and every 100-150 pulses with no issues or irregularities noted.Approximately 50ml of solta medical cryogen and coupling fluid was used during this treatment.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.Based on the evaluation of the data logs, the handpiece and system performed as expected.Discomfort, redness and blisters are all known possible adverse patient reactions to a thermage treatment.The service confirmed tip membrane damage during evaluation.Based on the available information, damage to the tip membrane of the tip most likely contributed to this event.It is unknown how the damage to the tip membrane occurred.All thermage tips are inspected for defects before shipment to customers.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 9652898
• MDR Text Key: 185891638
• Report Number: 3011423170-2020-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention