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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Anxiety (2328); Discomfort (2330)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional medical, product information and product has been requested, but not received.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician's office reported they received notification from a patient's attorney indicating the patient experienced surface irregularities post laser facial treatment.Legal documentation received states the consumer received one laser facial treatment, during which the aesthetician indicated there were irregularities in the procedure, including improper machine settings.The document indicates the consumer received permanent facial surface irregularity, pain, discomfort, suffer, stress, anxiety and worry.Additional medical information has been requested, but not received.

Manufacturer Narrative

Surface irregularities are known possible adverse patent reactions to thermage treatment.Surface irregularities are variously described as (localized) ¿small dents in the surface of the skin,¿ ¿rippling,¿ ¿ridging,¿ ¿wave patterns¿, or ¿fat loss¿ (covering a larger surface area).Frequently, surface irregularities are not evident immediately post-treatment, but show up later (1 or more months post-treatment).In most cases solta recommends that surface irregularities be monitored for a period of six months post onset.Tissue fillers may be considered as a treatment option if the condition does not resolve on its own.At this time, no additional information has been provided.Despite requests, no product has been returned for evaluation.It is unknown what settings were used during treatment.Based on the available information, no causal factor 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: 9490741
• MDR Text Key: 179263836
• Report Number: 3011423170-2019-00120
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other