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

Model Number TTNS3.00E4-1200

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested.A review of the device history logs is in progress.Based on available information, no conclusion can be drawn.

Event Description

A physician reported that while performing a thermage treatment on the patient's abdomen, the patient experienced burns on both calves, where the return pads were located.The patient began to feel discomfort at the first return pad site, however, treatment was continued until the patient had to stop the treatment due to the severity of pain at the return pad site on calf.The return pad was removed and the site was red.The return pad was moved to the other calf and treatment was started again at same treatment level.The second calf was also burned from the treatment pad.The patient experienced third degree burns on both calves where the return pads were located during the treatment.The burns were treated with an unknown ointment.Photographs were provided and reviewed.The patient is recovering, however permanent scarring is expected as a result of the event.The highest treatment level used was 9.5.An unspecified error code occurred during the procedure.The treatment tips were inspected before the treatment began, however, it is unknown how often the tip was inspected during the treatment.

Manufacturer Narrative

The treatment tip is not available for return.A review of the manufacturing records showed that all the requirements were met.The data card log confirmed that the system worked as designed.Based on the evaluation of the data, the system and hand piece performed as expected.The customer treated the patient at the highest setting.Caution should be used when selecting the treatment levels.The risks of adverse outcomes may be associated with elevated treatment levels.The return pad should be applied in a well vascularized area that is free of hair and tattoos and that has minimal curvature.The customer did not follow instructions for use by placing the return pad on an area with extreme curvature.Based on the available information, this treatment was performed in an off-label manner that resulted in unsafe conditions for the patient.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• MDR Report Key: 9733367
• MDR Text Key: 185892792
• Report Number: 3011423170-2020-00022
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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?: No
• 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: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other