BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES

    MDR report key: 15009219 · Received July 13, 2022

    Report

    Report Number
    3011423170-2022-00093
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 16, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K170758
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR AN EVALUATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE PATIENT DID NOT RECEIVE SUPERFICIAL MICRO BURNS ON HER SKIN AND THERE WAS NO ADVERSE EVENT. THE FOLLOWING FIELDS WERE CORRECTED: B1: CHANGED FROM ADVERSE EVENT AND PRODUCT PROBLEM TO PRODUCT PROBLEM. D4: CHANGED LOT # FROM 122820004 TO 122820-004. H1: CHANGED FROM SERIOUS INJURY TO MALFUNCTION. H6: HEALTH EFFECT CLINICAL CODE: 2685 WAS REMOVED. H6: HEALTH EFFECT IMPACT CODE FROM 4614 TO 4613. THE DATACARD LOG WAS RETURNED FOR EVALUATION. BASED ON THE EVALUATION OF THE DATA, THE HAND PIECE AND SYSTEM PERFORMED AS EXPECTED. THE TREATMENT TIP HAS NOT BEEN RETURNED FOR AN EVALUATION YET; HOWEVER THE TIP HAS BEEN REQUESTED TO BE RETURNED. SHOULD THE TIP BE RETURNED, A FOLLOW UP WILL BE SUBMITTED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. DAMAGE TO THE TREATMENT TIP WHERE THE MEMBRANE IS BROKEN COULD RESULT IN PATIENT BURNS. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP WAS RETURNED AND EVALUATED. SERVICE WAS UNABLE TO CONFIRM SPARKING OF THE TREATMENT TIP. THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A THERMAGE TREATMENT, THE FACIAL TIP STARTED TO SPARK AND THE PATIENT COMPLAINED OF PAIN. THE PATIENT RECEIVED SUPERFICIAL MICRO BURNS ON HER SKIN. AFTER 60 SHOTS THE TIP WAS CHANGED. NO FURTHER INFORMATION ON THE PATIENT AND EVENT ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418104 THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TT4.00F6-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female