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

Model Number TTNS3.00E2-900

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The treatment tip is not available for return, as it has been discarded.Lot information has been requested but not yet received.Based on all the available information no casual factors can be determined and no conclusions can be drawn.

Event Description

A physician reported that a consumer experienced blisters on their face after undergoing a thermage treatment.After the procedure the physician applied scald ointment and ice to the red and swollen areas.The blisters were noticed the next day and no additional treatment was prescribed.It is unknown at this time if there will be permanent damage of scarring.Prior to starting treatment, the patient requested that an energy level of 12 be used during the procedure.The physician advised the patient that the highest level of energy that could be used was an 8 and advised that blisters may occur if the requested level is used.During the procedure the physician lowered the energy level to 6.5.No errors occurred during treatment and it was the first time the tip was used.The tip was inspected prior to treatment and after every 100 pulses during.The treatment tip is no longer available for return.

Manufacturer Narrative

Burns, blisters, scabbing, and scarring are all known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual (p009240-05 rev.B) states the procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.It is the physician responsibility to ensure the treatment is being performed in a safe manner and adequate education is provided to the patient about possible adverse events.The treatment tip was discarded and the treating clinic refuses to provide the log data.Based on the available information, no causal factors can be determined and no conclusion can be found.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n; ste 100; bothell WA 98011
• MDR Report Key: 10361687
• MDR Text Key: 201897535
• Report Number: 3011423170-2020-00062
• 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: 01/01/2005,05/07/2020

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: TTNS3.00E2-900
• Device Catalogue Number: TTNS3.00E2-900
• 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
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR