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

Model Number TTNS3.00E4-900

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 11/27/2021

Event Type  Injury  

Manufacturer Narrative

The treatment tip was discarded by the treatment facility and is therefore not available for return and evaluation.The lot number is currently unknown so no batch record analysis is possible.Based on all available information no conclusion can be drawn and no cause established.

Event Description

A patient called to report that they experienced blisters on their right cheek immediately following a thermage cpt treatment they received approximately 2 months prior to reporting the event.The patient indicated they went to the hospital for treatment, where they were prescribed epidermal growth factor.The patient reported that despite that treatment and another laser therapy they still have hyperpigmented lesions on the burned area.The treating doctor was contacted to provide clinical information related to this event.The doctor reported that they performed a full face thermage cpt treatment at a maximum power level of 3.5.Ample coupling fluid was used during treatment, and it was reported the treatment tip was inspected prior to and throughout the treatment with no abnormalities noted.The doctor noted that they treated the left face and forehead first with no issue, but the patient reported increased pain when the right side of the face was treated.The doctor reduced the power level at the time of the reported pain and re-inspected the treatment tip without noting any issue.The treatment was completed at the lower power level.Following treatment, the doctor observed erythema and blisters forming on the right side of the face.The doctor then re-inspected the treatment tip and noted that the edge of the tip was broken.The patient was administered an unidentified burn ointment and epidermal growth ointment, as well as undergoing an ipl treatment.The patient is currently under treatment in a medical center.The current status of the patient is reported as hyperpigmentation and the possibility of permanent scarring is unknown but noted as unlikely.

Manufacturer Narrative

The treatment tip was discarded by the treatment facility and is therefore not available for return and evaluation.The lot number is currently unknown so no batch record analysis is possible.Based on all available information no conclusion can be drawn and no cause established.

Event Description

A patient called to report that they experienced blisters on their right cheek immediately following a thermage cpt treatment they received approximately 2 months prior to reporting the event.The patient indicated they went to the hospital for treatment, where they were prescribed epidermal growth factor.The patient reported that despite that treatment and another laser therapy they still have hyperpigmented lesions on the burned area.The treating doctor was contacted to provide clinical information related to this event.The doctor reported that they performed a full face thermage cpt treatment at a maximum power level of 3.5.Ample coupling fluid was used during treatment, and it was reported the treatment tip was inspected prior to and throughout the treatment with no abnormalities noted.The doctor noted that they treated the left face and forehead first with no issue, but the patient reported increased pain when the right side of the face was treated.The doctor reduced the power level at the time of the reported pain and re-inspected the treatment tip without noting any issue.The treatment was completed at the lower power level.Following treatment, the doctor observed erythema and blisters forming on the right side of the face.The doctor then re-inspected the treatment tip and noted that the edge of the tip was broken.The patient was administered an unidentified burn ointment and epidermal growth ointment, as well as undergoing an ipl treatment.The patient is currently under treatment in a medical center.The current status of the patient is reported as hyperpigmentation and the possibility of permanent scarring is unknown but noted as unlikely.

Event Description

Available pictures were provided and reviewed.In the first picture, marked as immediately post procedure, a large area of inflammation is visible on one side of the patient face.The second picture, marked as three days post procedure, blisters, crusts, and post inflammatory hyperpigmented areas are visible on one side of the patient face.In the third picture, marked as one month post procedure, inflammation and blisters are recovered with visible hyperpigmented areas.

Manufacturer Narrative

New clinical information was received and entered into section b5.

Manufacturer Narrative

Correction to h5: changed from "no" to "yes".The data logs were reviewed however did not include data from the reported treatment date.The tip was not returned for evaluation.According to thermage cpt user manual, burns and pigment changes are known potential reactions to treatment.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.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.No solta serial/lot number was reported for this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 n creek pkwy north; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy north; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609 ; 5853386853
• MDR Report Key: 13552435
• MDR Text Key: 286009682
• Report Number: 3011423170-2022-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female