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

Model Number TTNS3.00E4-1200

Device Problem Insufficient Information (3190)

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

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

The tip has been requested but not yet received.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A patient reported getting burns and blisters on the forehead and neck immediately after undergoing a thermage treatment.The patient was placed under an unknown topical anesthetic during the treatment.Available photos were reviewed.Erythema on both cheeks is visible.On one side of the neck large post inflammatory hyperpigmented patches are visible.On the upper part of the forehead erythema is visible.The same area shows recovering blisters and hyperpigmented areas.The patient is currently recovering the blisters are gone.It is unknown whether there will be any permanent scarring.The highest energy level used was 3.5.It was reported that enough amount of cryogen fluid was used.The tip was inspected prior to treatment and nothing unusual was noted.The tip was not inspected during the procedure.No system errors were reported.

Manufacturer Narrative

Treatment tip was returned and evaluated and no issues were found.Tip passed visual inspection, leak test, and thermistor test.Functional test was not performed due to the tip being expired.The review of the system/data logs does not indicate there was any handpiece or system issue present.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.Information from the clinic reported no system errors or anything out of the ordinary occurred during treatment.Based on the evaluation of the data, the handpiece and system performed as expected.Evaluation of the tip found no issues related to this event.Based on the available information burns and blisters are known potential reactions to 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 14609
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman street north; rochester, NY 14609 ; 5853386853
• MDR Report Key: 13589018
• MDR Text Key: 288690262
• Report Number: 3011423170-2022-00022
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2022

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: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/14/2022; 04/14/2022
• Supplement Dates FDA Received: 05/12/2022; 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female