MAUDE Adverse Event Report: SOLTA MEDICAL INC THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT3.00F6-900

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Inflammation (1932); Blister (4537)

Event Date 01/22/2022

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 distributor reported that a patient experienced burns and blisters on the left side of the face after a thermage treatment.The patient was given an unknown topical anesthetic prior to treatment.Post ¿ treatment the patient was treated with burn ointment and an unknown skin care product that promotes healing.It is unknown whether there will be any permanent scarring.Available photos were reviewed.Inflammation is visible on the patient''s cheek and show large blisters at the site of inflammation.The tip was inspected before treatment and every 50-80 pulses during treatment, nothing unusual was noted.The highest energy level used was 4 and enough cryogen fluid was used.During treatment, an error message of ¿tip can''t be recognized¿ was observed.

Manufacturer Narrative

The tip was returned and evaluated.Tip passed thermistor testing, leak test, and visual inspection.No functional test was performed due to the tip being expired.The review of the system/data logs does not indicate there is 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

Evaluation of the treatment tip found no issues related to this event.Tip passed incoming leak, visual, and thermistor tests.No dents, scratches, blemishes, or dielectric breakdown observed.A review of the manufacturing records showed all requirements were met.Datalogs confirmed the system and handpiece performed as expected.Evaluation of the treatment tip found no issues.Based on the available information, blisters are a known possible side effect during a thermage flx treatment.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman street north; rochester, NY 14609 ; 5853386853
• MDR Report Key: 13580982
• MDR Text Key: 286009832
• Report Number: 3011423170-2022-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT3.00F6-900
• Device Catalogue Number: TT3.00F6-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female