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

Model Number TTNS3.00C3-600

Device Problem Dent in Material (2526)

Patient Problems Erythema (1840); Rash (2033); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The reporter confirmed that prior to the treatment, the tip was inspected and nothing was noted on the surface.The tip was returned and evaluated and the headpiece and system performed as expected.The tip passed flow, leak, thermistor and functional testing.The visual inspection of the tip failed due to a dent.The thermage system's' data card was evaluated.Analysis of the data determined that a thermistor disconnected error occurred starting at rep 369.The tip was removed and reattached several times before the doctor discontinued the use of this tip and attached a second tip.A review of the manufacturing records showed all requirements were met.Based on the available information, burns, blisters, scabbing, and scarring are known possible adverse patient reactions to thermage treatment.

Event Description

A clinic reported that while receiving a thermage treatment on the full face, excluding the forehead, a patient experienced redness, rashes and swelling under the jaw.Ice compression, betamethasone valtrate and vasoline were applied.The doctor stated at the time of the report that the patient had three blisters located under the jaw and one on the temple.At a follow up consultation one month later, the doctor stated that the scabs have fallen and there is new, thin skin that may become pigmented.Hydroquinone was prescribed for both internal and external use.Photographs are available and were reviewed.The patient underwent ultralift double hifu on the face and the neck and iontophoresis 13 days prior to the thermage treatment.Iontophoresis was also performed after the thermage treatment.The highest energy level used was 4.0 on the face and 3.5 for under the jaw.During the treatment a thermister disconnected error occurred frequently, however was rectified by using a new tip.The tip was inspected prior to treatment with no irregularities or issues noted.During the procedure, the tip was not inspected.Cryogen and coupling fluid was used during the treatment.

• 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
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 n goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 9739079
• MDR Text Key: 185893216
• Report Number: 3011423170-2020-00030
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00C3-600
• Device Catalogue Number: TTNS3.00C3-600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• 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: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention