BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE FLX (TG-3A) AND ACCESSORIES

    MDR report key: 20955742 · Received December 17, 2024

    Report

    Report Number
    3011423170-2024-00236
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 18, 2024
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K170758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP WAS RETURNED FOR EVALUATION. THE TIP PASSES LEAK AND THERMISTOR TESTING. THE TIP FAILED VISUAL INSPECTION, AS A DENT WAS OBSERVED. IT IS UNCLEAR WHEN AND HOW THE DENT OCCURRED, BUT IT IS NOT LIKELY TO HAVE ATTRIBUTED TO THE ADVERSE EVENT. NO FUNCTIONAL TESTING COULD BE COMPLETED AS THE TIP WAS EXPIRED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AS PREVIOUSLY REPORTED, SERVICE FOUND A DENT ON THE TIP. THE DENT WOULD NOT CAUSE RISK TO PATIENT SINCE RADIOFREQUENCY ENERGY IS ABLE TO DISTRIBUTE EVENLY ACROSS THE MEMBRANE. THE DATA LOGS WERE EVALUATED. THE SYSTEM HAS SOFTWARE SAFEGUARDS (SUCH AS A POWER ON SELF-TEST) THAT WILL TRIGGER ERROR/EVENT CODES SHOULD SYSTEM BE OUTSIDE OF ACCEPTABLE LIMITS. WHEN THE SYSTEM DETECTS A CONDITION THAT INTERRUPTS TREATMENT, A SYSTEM ERROR CODE IS DISPLAYED. THESE SYSTEM ERROR CODES PROVIDE AN ERROR CODE NUMBER AND INSTRUCTIONS FOR HOW TO RESPOND TO THE ERROR. IN THE EVENT OF A SYSTEM ERROR, CUSTOMERS NEED TO INTERVENE TO PROCEED. THE FOLLOWING MESSAGES WERE RECEIVED DURING THE USER TREATMENT: TIP LIFTED PREMATURELY, TIP TOO WARM, ERROR FORCE ACTIVATION, MAX RADIOFREQUENCY POWER DELIVERED, RADIOFREQUENCY ERROR. THE REVIEW OF THE SYSTEM/DATA LOGS DOES NOT INDICATE THERE IS ANY HANDPIECE OR SYSTEM ISSUE PRESENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS EVENT WHEN REVIEWING THE DEVICE HISTORY RECORD. ACCORDING TO THERMAGE FLX USER MANUAL, PAIN, REDNESS, SWELLING, AND BLISTERS ARE KNOWN POSSIBLE SIDE EFFECTS DURING A THERMAGE FLX TREATMENT. THE PROCEDURE PRODUCES HEATING IN THE UPPER LAYERS OF THE SKIN AND MAY CAUSE 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. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS A KNOWN POSSIBLE SIDE EFFECT OF THERMAGE FLX TREATMENT. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN, REDNESS, SWELLING, AND BLISTERS ON THE LEFT OCCIPITAL AND PAROTIDEOMASSETERIC REGION AND WHOLE ANTERIOR NECK AFTER A THERMAGE FLX TREATMENT OF THE FULL FACE AND NECK. IMMEDIATELY AFTER THE TREATMENT, LARGE RED SWOLLEN PATCHES APPEARED ON LEFT FACE AND NECK. BLISTERS WERE FOUND AT MULTIPLE AREAS AFTER RETURNING HOME THAT EVENING. AFTER THE TREATMENT, THE REDNESS AND SWELLING WERE REPORTEDLY RELATIVELY ABNORMAL. A DERMATOLOGIST CONFIRMED ON THE NEXT DAY THAT THOSE WERE SECOND DEGREE BURNS. AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. MULTIPLE BLISTERS ARE VISIBLE ON ONE SIDE OF PATIENT'S FACE AND BOTH SIDES OF NECK. ON PICTURES DATED DAY TWO, BLISTERS WERE HEALING WITH POST INFLAMMATORY HYPERPIGMENTED (PIH) AREAS REMAINING ON NECK AND FACE. SOME BLISTERS WERE STILL VISIBLE. (THE TIMING OF THE PICTURES POST EVENT ARE NOT CLEAR; ON A PICTURE DATED DAY TWO ONLY BURNED AREAS PRIOR TO BLISTERS ARE VISIBLE) PICTURES DATED DAY FOUR, SOME BLISTERS ARE VISIBLE ON THE NECK, SOME BLISTERS ARE HEALING WITH PIH REMAINING. DAY FOUR PICTURES OF THE FACE, BLISTERS ARE HEALING WITH PIH. PICTURES DATED DAY 14, SOME WOUNDS ARE HEALED, AND SOME WOUNDS ARE CRUSTED. SCARS FROM THE HEALED WOUNDS ARE VISIBLE. THE TREATMENT WAS PERFORMED FIRST OF THE RIGHT FACE WITH NO ANOMALIES NOTED, HOWEVER, UPON STARTING THE LEFT FACE ERROR MESSAGES WERE RECEIVED. THE REPORTER STATED THAT TWO ERRORS OCCURRED, PRIMARILY A CONNECTION ERROR. AFTER RECONNECTING THE BODY CONDUCTIVE PAD, THERE WERE NO MORE ERRORS. THE HIGHEST ENERGY LEVEL WAS 4. AN EYE SHIELD WAS USED WITH NORMAL SALINE LUBRICATION. LOCAL ANESTHESIA WAS ADMINISTERED ALONG WITH LIGNOCAONE OINTMENT BEFORE THE TREATMENT. THE HIGHEST ENERGY LEVEL USED WAS 4. THIS TREATMENT WAS THE INITIAL USE OF THE TREATMENT TIP. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND FOUND TO BE SMOOTH AND NORMAL. AFTER TREATMENT, THE TIP WAS REPORTEDLY UNEVEN. ICE PACKING WAS APPLIED IMMEDIATELY AFTER TREATMENT, AND NSAIDS WAS PRESCRIBED AFTER THE PROCEDURE. DAILY DRESSING AND SUDOCREAM WAS USED POST PROCEDURE. THE WOUNDS ARE REPORTEDLY HEALING WITHOUT INFECTION. THE PATIENT REPORTED THAT THE RECOVERY IS NOT COMPLETE ONE MONTH POST PROCEDURE. THE PATIENT REPORTED THAT IT IS SERIOUSLY IMPACTING THEIR WORK AND LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279044 THERMAGE FLX (TG-3A) AND ACCESSORIES ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI GEI SOLTA MEDICAL, INC. TT4.00F6-900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female