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

Model Number TTNS3.00E4-1200

Device Problems Dent in Material (2526); Insufficient Information (3190); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Skin Discoloration (2074); Burning Sensation (2146)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record is in progress.Product has been requested but not yet received.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 experienced a burn on the left side of their face and neck following a thermage treatment.The patient was administered a topical anesthetics prior to treatment, and underwent a full face treatment.With around 200 reps remaining the patient complained of a burning sensation.Post treatment it was noted that the left side of the patients face had brown blood stains and scratches on the skin.The patient was immediately treated with an ice pack, mask, and instructed to use an ice compress to treat any burns experienced.The current patient status was noted as obvious hyperpigmentation on the left side of the face.The physician indicated the treatment was performed at a maximum energy level of 3.5 and that the treatment tip was inspected prior to and during the treatment, every 50 to 100 pulses, with no observed abnormalities.The physician reported using ample coupling fluid throughout the treatment.Near the end of treatment the doctor observed an error indicating ''activation button released rf on''.

Manufacturer Narrative

The tip used during treatment was returned and evaluation was completed.The tip passed flow testing, but failed leak testing, thermistor testing, and visual inspection for a damaged corner.Functional testing was not possible due to the damage on the tip.During evaluation of the treatment tip, product support found damage to the corner of the tip membrane.Solta medical has confirmed a low incidence (less than (b)(4) of the total estimated number of treatments) of first- and second-degree patient burns associated with damage of the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Damage to the membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area.A review of the manufacturing records showed all requirements were met.Burns, blisters, and scabbing are all known possible adverse patient reactions to thermage treatment.Service confirmed tip membrane damage during evaluation.Based on the available information, damage to the tip membrane most likely contributed to this event.It is unknown how the damage to the tip membrane occurred as 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: 9738748
• MDR Text Key: 185893038
• Report Number: 3011423170-2020-00029
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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: 05/01/2020
• 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: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention