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

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Product information and product retrieval is not available as the hospital confirmed they have never treated the reporting consumer.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.

Event Description

A consumer reported that post a thermage facial treatment they developed blisters and scabs on their right cheek.The consumer stated the treating doctor would not provide treatment for the blisters.Through a follow-up conversation with the consumer, they indicated they now have a permanent scars.Photographs were asked for, but not provided.The consumer will not provide any additional information.Through a follow-up conversation with the doctor whose information was provided by the consumer, the doctor has no record of treating the reporting patient.They indicated they do have thermage equipment, however do not use the type of tip the consumer indicated.

Manufacturer Narrative

Follow up with patient revealed they did not wish to provide additional information in regards to the event.The treating hospital indicated they have not seen the patient and they don't use the treatment tip described by the patient (cpt tip-600).The hospital denied any adverse events occurring.It was reported the hospital tried to contact the patient that reported the event but they could not be reached.No treatment information or product could be returned.According to thermage cpt system technical user¿s manual burns, blisters, scabbing, and scarring are known possible patient reaction to thermage treatment.Based on the available information, no causal factors can be determined and no conclusions can be drawn.

• 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: 10508298
• MDR Text Key: 206329344
• Report Number: 3011423170-2020-00076
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other