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

Model Number TH-6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

The product tips were not returned however the system hand piece was evaluated.The lee valve was partially plugged and contaminants were prevalent within the hand piece, and the vibration mount was cracked.The lee valve, inline filter, vibration motor and vibration motor mount were replaced.Unit passed all tests.The system was serviced and the cryogen pump and arrestor was replaced.System tested ok.A review of the device history records is in progress.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctors office reported that a patient began a laser treatment on their chin and full face.About 40 minutes into the treatment the first tip started to show error code indicating the tip was too warm, however the reporting office confirmed that tip was actually cold and observed frost on the tip.The first tip was used on the right side of the face where red spots later appeared.The physician then added more coupling gel and increased time between treatment pulses, however the error code persisted.The physician then swapped to a second treatment tip.The second tip was used for 248 shots and then the same error code occurred.This tip was also used on the right side of the face.Again the treatment was slowed but the error persisted, and again the tip felt cold to the touch.After shot 250 the physician swapped to a third treatment tip.The third tip worked without any errors and the treatment was completed using this tip.In total the patient was treated with 900 shots across the face and chin at a level of 2.0 and 2.5.After the treatment was complete the patient complained that they felt pain on the right side of their face.Red spots were observed by the treating physician on the right side of the patients face.Available photos were reviewed and showed the patient had some redness and small blisters on the right side of their face.

Event Description

After confirmation of the complaint information provided by the reporter, it was determined the patient experienced mild pain and discomfort on the right side of the face, not a burn which was initially reported.An additional medical review determined there is now insufficient information to suggest a serious injury has occurred and has been re-assessed as not serious.Therefore, this event is no longer considered a reportable event.

Manufacturer Narrative

Initial report of burn was created, with minimal information and later confirmation of information provided indicated the patient did not experience a burn only pain and discomfort.Further review determined there is insufficient information to suggest a serious injury has happened and has been re-assessed as not serious.Therefore, this event is no longer considered a reportable event.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 8795546
• MDR Text Key: 151202746
• Report Number: 3011423170-2019-00076
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TH-6
• Device Catalogue Number: TH-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• 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: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other