THERMAGE FLX TT4.00F6-900Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00816995021438), received between Jan 7, 2024 and Aug 19, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Excessive Heating” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s); Erythema; Localized Skin Lesion; Skin Discoloration; Skin Erosion; Skin Inflammation/ Irritation

  MAUDE report 50333327 ↗
• InjuryMar 25, 2026Insufficient Cooling

  A USER FACILITY REPORTED DEEP AND SHALLOW BLISTERS ON BOTH CHEEKS, THE CHIN, AND TEMPLES FOLLOWING A THERMAGE FLX TREATMENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A BURNING SENSATION ON THE SKIN AND REPORTED THAT THE DEVICE FELT LUKEWARM COMPARED TO PRIOR TREATMENTS, WHICH FELT COLD. CORTISONE OINTMENT AND INTRAMUSCULAR DEXAMETHASONE WERE ADMINISTERED AS SECONDARY INTERVENTIONS. AT APPROXIMATELY ONE AND A HALF MONTHS POST-TREATMENT, THE PATIENT'S CONDITION WAS REPORTED AS POST-INFLAMMATORY HYPERPIGMENTATION (PIH) WITH DENTED SCARRING. PERMANENT DAMAGE AND SCARRING ARE EXPECTED PER THE PHYSICIAN'S REPORT. THREE PHOTOGRAPHS, WITH NO SPECIFIED TIMEPOINTS, WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. THE IMAGES SHOWED MULTIPLE ERYTHEMATOUS INFLAMMATORY LESIONS AND HYPERPIGMENTED MACULES DISTRIBUTED PREDOMINANTLY ON THE CHIN AND BILATERAL LOWER CHEEKS, WITH ACTIVE PAPULES AND POST-INFLAMMATORY CHANGES VISIBLE. A SECOND IMAGE SHOWED FEWER INFLAMMATORY LESIONS, WITH RESIDUAL ERYTHEMA AND HYPERPIGMENTED MACULES ON THE LOWER FACE AND CHIN. A THIRD IMAGE SHOWED FURTHER IMPROVEMENT, WITH FAINT RESIDUAL DISCOLORATION AND MINIMAL ERYTHEMA. WHILE THE IMAGES LACK DATE CONFIRMATION, THEY S

  Patient problems: Blister; Erythema; Hyperpigmentation; Localized Skin Lesion; Scar Tissue; Skin Burning Sensation; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 24687473 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT FOLLOWING A THERMAGE FLX FACIAL TREATMENT LATER IN THE DAY A PATIENT EXPERIENCED A HEAT SENSATION, GUM INFLAMMATION, SORENESS, REDNESS, AND DIFFICULTY CHEWING. ADDITIONALLY, THE PATIENT EXPERIENCED A TOOTH FRACTURE A FEW DAYS AFTER THE PROCEDURE. THE PATIENT CONSULTED A DENTIST AND EXPLAINED THE PROCEDURE PERFORMED. THE DENTIST SUGGESTED THAT THE SYMPTOMS MIGHT BE RELATED TO THE RADIO FREQUENCY TREATMENT. THE PATIENT SUBSEQUENTLY CONTACTED THE CLINIC TO INQUIRE WHETHER SIMILAR CASES HAD BEEN REPORTED AND TO SEEK GUIDANCE. AT THE TIME OF REPORTING, THE PATIENT¿S STATUS WAS DESCRIBED AS GOOD; HOWEVER, THE PATIENT EXPERIENCED A BROKEN TOOTH FOLLOWING THE PROCEDURE, WHICH INDICATES PERMANENT DAMAGE. NO SECONDARY INTERVENTIONS WERE REPORTED BY THE USER FACILITY. THE PATIENT REPORTED REGULARLY TAKING HORMONE REPLACEMENT THERAPY, MAGNESIUM, AND OMEGA-3 SUPPLEMENTS AND REPORTED ROUTINE USE OF SUNSCREEN. THE HIGHEST ENERGY USED WAS REPORTED AS AN ACCUMULATED LEVEL OF 18 MJ USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND APPROXIMATELY 1.5 TO 2 BOTTLES OF UNSCENTED SOLTA COUPLING FLUID TO COMPLETE THE TREATMENT. THE UNUSED TREATMENT

  Patient problems: Burning Sensation; Difficulty Chewing; Pain; Swelling/ Edema; Tooth Fracture

  MAUDE report 24590506 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVAILABLE INFORMATION WAS RECEIVED AND REVIEWED BY THE MEDICAL REVIEWER. IT WAS REPORTED THAT NO SECONDARY INTERVENTION WAS REQUIRED, THE AFFECTED AREA FULLY RECOVERED, AND NO PERMANENT SCARRING IS EXPECTED. TWO PHOTOGRAPHS OF THE PATIENT¿S FOREHEAD WERE REVIEWED; BOTH IMAGES WERE UNDATED. ONE IMAGE SHOWED A SMALL BLISTER, WHILE THE SECOND IMAGE DEMONSTRATED A HEALING BLISTER WITH RESIDUAL ERYTHEMA AND SMALL CRUSTS. BASED ON THE REPORTED FULL RECOVERY, ABSENCE OF PERMANENT SCARRING, AND NO REQUIREMENT FOR SECONDARY INTERVENTION, THE EVENT WAS REASSESSED AS NON-SERIOUS. THIS CASE NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Blister; Burn(s)

  MAUDE report 22740275 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED SWELLING AND WAS DIAGNOSED WITH PANNICULITIS FOLLOWING A THERMAGE FLX TREATMENT. THE PATIENT REPORTED SWELLING ON THEIR FACE APPROXIMATELY 2 MONTHS POST PROCEDURE. THE PATIENT SOUGHT MEDICAL ATTENTION AT A HOSPITAL IN CHINA WHERE THE PHYSICIAN NOTED INFLAMMATION THAT APPEARED TO BE A CHRONIC SUBCUTANEOUS CONDITION. THE PATIENT WAS DIAGNOSED AT THAT TIME WITH PANNICULITIS AND ADVISED THAT THE THERMAGE FLX TREATMENT COULD NOT BE RULED OUT AS A POSSIBLE CAUSE. THE PATIENT WAS THEN PRESCRIBED CORTICOSTEROID MEDICATION. THE PATIENT HAD NOT UNDERGONE ANY OTHER PROCEDURE IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. IN THEIR PAST HISTORY, THE PATIENT HAS RECEIVED COLLAGEN-STIMULATING INJECTABLES INCLUDING PLLA-BASED PRODUCTS AND BELLAFILL, RADIO-FREQUENCY MICRONEEDLING, AND IPL TREATMENTS, WITH NO ADVERSE REACTIONS. THE PATIENT¿S CURRENT STATUS IS THEY ARE TAKING CORTICOSTEROID MEDICATION UNDER MEDICAL SUPERVISION AND IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. A SOLTA MEDICAL REVIEWER EXAMINED IMAGES OF THE PATIENT. A TOTAL OF FIVE UNDATED IMAGES WERE PROVIDED, WHICH APPEARED TO SHOW PROGRE

  Patient problems: Subcutaneous Nodule; Swelling/ Edema

  MAUDE report 22532596 ↗
• InjuryMar 14, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS ON THEIR FOREHEAD ALONG THE HAIRLINE DURING A THERMAGE FLX TREATMENT OF THE FACE AND NECK. IT WAS OBSERVED DURING THE PROCEDURE THERE WERE SEVERAL MINOR BURN AREAS ON THE FOREHEAD ALONG THE HAIRLINE. THE FOREHEAD WAS CLEANSED, AND SILVER SULFADIAZINE WAS APPLIED TO THE AFFECTED AREAS. DURING THE TREATMENT, THE CLINIC REPORTED HEARING A CRACKLING SOUND . THE SYSTEM SHOWED AN ERROR CODE OF EC78C AND DISPLAYED A WARNING THAT THE TIP WAS TOO WARM. SOLTA MEDICAL BRANDED CRYOGEN AND A ¿SUFFICIENT¿ AMOUNT OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 2.0. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT. IT WAS INSPECTED PRIOR TO USE AND THROUGHOUT THE PROCEDURE EVERY TIME A ¿CRACKLING SOUND¿ WAS HEARD. NO DISCREPANCIES ON THE TIP WERE FOUND BEFORE OR DURING THE TREATMENT. THE TREATMENT TIP WAS NOT RETAINED FOR EVALUATION. THE PATIENT HAD RECEIVED SKINBOOSTER AND PICOPLUS LASER TREATMENT TO THE SAME SYMPTOM AREA WITHIN 90 DAYS OF THE PROCEDURE DATE. NO OTHER TREATMENTS WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE. A SOLTA MEDICAL REVIEWER EXAMINED A PHOTO TAKEN THREE DAYS POST-PRO

  Patient problems: Burn(s); Hyperpigmentation; Scar Tissue

  MAUDE report 21608910 ↗
• InjuryMar 7, 2025Leak/Splash; Leak/Splash

  A USER FACILITY REPORTED REDNESS DURING A THERMAGE FLX TREATMENT TO THE NECK. POST-TREATMENT, THE PATIENT EXPERIENCED HYPERPIGMENTATION AND SCARRING. TWO CRYOGEN POOLS, BOTH THE SIZE OF NICKEL, WERE NOTICED ON PATIENT'S NECK DUE TO CRYOGEN BEGINNING TO LEAK BETWEEN THE HANDPIECE TIP CARRIAGE AND THE THERMAGE TIP. WHEN THE CRYOGEN WAS REMOVED, THE CUSTOMER NOTICED BOTH AREAS WERE RED. THE CUSTOMER ELECTED TO STOP TREATMENT AT THAT POINT SINCE THEY WERE NEAR THE 900-PULSE COUNT. THE CUSTOMER PROVIDED THE PATIENT WITH HYDROCORTISONE TO APPLY TO THE TWO SITES. APPROXIMATELY 6 WEEKS POST TREATMENT (UPON RETURN FROM HOLIDAY TRAVEL), THE PATIENT CONTACTED THE USER FACILITY TO REPORT THE TWO SITES APPEARED TO HAVE HEALED BUT NOTICED HYPERPIGMENTATION. TREATMENTS WITH HYDROQUINONE AND DISCOVERY PICO LASER WERE INITIATED TO TARGET PERSISTENT PIGMENTATION. PATIENT PHOTOS WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER: DAY OF TREATMENT: MILD REDNESS IS VISIBLE ON THE SIDE OF THE NECK POST-PROCEDURE. FIVE WEEKS POST TREATMENT: TWO RED AREAS SURROUNDED BY BROWN HYPERPIGMENTATION NOTED. SIX WEEKS, TWO DAYS POST TREATMENT: REDNESS RESOLVED; TWO MILD HYPERPIGMENTED AREAS REMAIN. THE PATIENT CONTINUES

  Patient problems: Erythema; Hyperpigmentation; Scar Tissue

  MAUDE report 21546348 ↗
• InjuryJan 27, 2025Excessive Heating; Excessive Heating

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A RED BLISTER OF THE RIGHT TEMPLE THE DAY AFTER A THERMAGE FLX TREATMENT OF THE FACE AND NECK. THE PATIENT APPLIED AQUAFOR AT HOME AND WAS GIVEN EXOSOMES DURING A FOLLOW UP APPOINTMENT. FOUR WEEKS POST PROCEDURE, THE PATIENT WAS GIVEN ADDITIONAL EXOSOMES. AT THAT TIME, THE PATIENT WAS STILL HEALING AND SEEMED TO BE GETTING BETTER. THE PATIENT REPORTEDLY EXPERIENCED REDNESS AND BRUISING DURING THE HEALING PROCESS. DURING THE TREATMENT, TIP TOO WARM ERROR(S) OCCURRED. THE HIGHEST LEVEL OF TREATMENT WAS 2.5-3.0. SOLTA MEDICAL BRANDED CRYOGEN WAS USED WITH AN UNKNOWN TOTAL AMOUNT OF COUPLING FLUID. COUPLING FLUID WAS APPLIED ON EVERY PASS AND BEFORE EVERY VECTOR. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO USE WITH NO DISCREPANCIES FOUND. THE TIP WAS NOT INSPECTED AT ANY TIME DURING THE TREATMENT. THE PATIENT HAD NOT RECEIVED ANY OTHER TREATMENT TO THE SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT HAS HISTORICALLY RECEIVED QUARTERLY CLEAR AND BRILLIANT TREATMENTS WITH APPLICATION OF BENZOCAINE, LIDOCAINE, AND TETRACAINE (BLT) CREAM PRIOR TO THE TREATMENT.

  Patient problems: Blister; Bruise/Contusion; Erythema

  MAUDE report 21246621 ↗
• InjuryJan 8, 2025Noise, Audible; Noise, Audible

  A PATIENT REPORTEDLY EXPERIENCED A BLISTER BELOW THE LEFT TEMPLE POST THERMAGE FLX FACIAL AND NECK TREATMENT. A PATIENT PHOTO WAS REVIEWED BY THE SOLTA MEDICAL REVIEWER. A BLISTER IS VISIBLE ON THE TEMPLE AREA; HOWEVER, THE QUALITY OF THE PICTURE IS INSUFFICIENT TO EVALUATE THE BLISTER THOROUGHLY. OTHER AREAS OF THE PATIENT'S FACE APPEAR ERYTHEMATOUS. MUPIROCIN AND BIAFINE OINTMENT WERE USED TO TREAT THE PATIENT¿S BLISTER. THE PATIENT IS CURRENTLY DESCRIBED AS ¿WITHIN NORMAL LIMITS,¿ WHICH WAS NOT DEFINED. IT IS UNCLEAR YET IF THERE WILL BE PERMANENT DAMAGE OR SCARRING. THE HIGHEST ENERGY LEVEL USED WAS 2.5. THE INCIDENT OCCURRED WITHIN THE FIRST 135 REPS OR UP TO 215 REPS. WHEN EIGHT REPS WERE LEFT, A CRACKLE SOUND WAS OBSERVED WHEN TREATING THE PATIENT¿S FOREHEAD. SOLTA CRYOGEN AND 7 BOTTLES OF SOLTA COUPLING FLUID WERE USED. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE, WITH NOTHING ATYPICAL NOTED, BUT WAS NOT INSPECTED DURING THE TREATMENT. THIS TREATMENT WAS THE INITIAL USE OF THE TREATMENT TIP. NO OTHER TREATMENTS WERE BEING PERFORMED IN THE SAME SYMPTOM AREA. THE PATIENT HAD NOT HAD AESTHETIC TREATMENTS WITHIN THE PRIOR 90 DAYS. THE PATIENT HAD A THERMAGE TREATMENT APPROXIMA

  Patient problems: Blister; Erythema

  MAUDE report 21105443 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED SMALL BILATERAL BURNS ON THE PATIENT'S CHEEKS AFTER A THERMAGE FLX PROCEDURE. AVAILABLE PHOTOS WERE ASSESSED BY THE MEDICAL REVIEWER AND CRUSTS ARE VISIBLE ON PATIENT'S CHEEKS ON BOTH SIDES. THOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 20857364 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A BURN AFTER A THERMAGE FLX TREATMENT. THOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 20843857 ↗
• InjuryDec 3, 2024Improper or Incorrect Procedure or Method; Material Deformation; Excessive Heating; Improper or Incorrect Procedure or Method; Material Deformation; Excessive Heating

  A USER FACILITY REPORTED THAT BURNS WERE OBSERVED ON THE PATIENT¿S TEMPLES, CHEEKS, AND CHIN APPROXIMATELY TWO HOURS AFTER PERFORMANCE OF A THERMAGE FLX FACIAL TREATMENT. THE PATIENT WAS ADMINISTERED FENTANYL (2AMP), ALFENTANIL (2AMP), AND PROPOFOL (50ML:2AMP) PRIOR TO THE TREATMENT. BEFORE THE TREATMENT, THE TREATMENT TIP WAS INSPECTED AND FOUND TO HAVE AN UNEVEN TIP MEMBRANE. THE TIP WAS REINSPECTED EVERY 2-3 PULSES THROUGHOUT THE TREATMENT. THIS WAS THE INITIAL USE OF THE TREATMENT TIP. DURING THE PROCEDURE, TIP TOO WARM MESSAGES WERE RECEIVED. THE HIGHEST ENERGY USED WAS 5MJ, USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND APPROXIMATELY 120ML OF UNSCENTED SOLTA COUPLING FLUID TO COMPLETE THE TREATMENT. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS. AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHICH IDENTIFIED MULTIPLE BURNED AREAS THAT LATER TURNED INTO LARGE BLISTERS ON MULTIPLE AREAS ON THE FACE, INCLUDING THE CHEEKS AND THE CHIN. THE PATIENT¿S BURNS WERE TREATED WITH CLOBETASOL CREAM AND ARTIFICIAL SKIN, WHICH REP

  Patient problems: Blister; Burn(s)

  MAUDE report 20832353 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVAILABLE INFORMATION WAS REVIEWED. IT IS REPORTED THAT PATIENT IS RECOVERING GRADUALLY, AND THE SCAR IS FADING. AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER AND A MILD HYPERPIGMENTED LESION IS OBSERVED ON THE UPPER CHEEK. THE CONDITION IS IMPROVING WITHOUT ANY TREATMENT BEYOND STANDARD CARE, AND THE RESIDUAL LESION IS NOT CLINICALLY SIGNIFICANT TO INDICATE A SERIOUS ADVERSE EVENT. THEREFORE, THE ASSESSMENT CHANGED TO NOT SERIOUS AND NO LONGER MEETS THE CRITERIA AS A REPORTABLE EVENT.

  Patient problems: Erythema; Hyperpigmentation

  MAUDE report 20785104 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BLISTER NEAR THE BELLY BUTTON AFTER A THERMAGE FLX TREATMENT TO THE ABDOMEN. NO OTHER TREATMENTS WERE BEING PERFORMED AT THE SAME TIME AS THE THERMAGE TREATMENT, AND THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS TO THE AREA. THE PATIENT WAS TREATED AT ENERGY LEVEL 4.0 FOR ALL 900 PULSES. AN ENTIRE BOTTLE OF SOLTA COUPLING FLUID WAS USED. NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT AND NOTHING OUT OF THE ORDINARY WAS OBSERVED. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND AFTER EVERY ZONE THROUGHOUT THE TREATMENT, WITH NOTHING ATYPICAL NOTED. THIS TREATMENT WAS THE INITIAL USE OF THE TREATMENT TIP. HYDROCORTISONE AND VASELINE WERE USED TO TREAT THE BLISTER. A PICTURE TAKEN AFTER THE TREATMENT WAS EVALUATED BY THE SOLTA MEDICAL REVIEWER AND SHOWS A BLISTER NEAR THE UMBILICUS. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 25 DAYS POST-TREATMENT INDICATES THAT THE PATIENT HAS RECOVERED BUT HAS SCARRED. A PICTURE FROM AROUND THIS TIME WAS EVALUATED BY THE SOLTA MEDICAL REVIEWER AND SHOWS A HEALING BLISTER WITH SCAR TISSUE.

  Patient problems: Blister; Scar Tissue

  MAUDE report 20282290 ↗
• InjuryJul 20, 2024Dent in Material; Dent in Material

  A USER FACILITY REPORTED REDNESS ON BILATERAL CHEEKS IMMEDIATELY AFTER A THERMAGE FLX TREATMENT OF THE FACE. TOPICAL NUMBING CREAM WAS APPLIED TO THE PATIENT PRIOR TO THE PROCEDURE AND ALOE VERA WAS USED IMMEDIATELY POST PROCEDURE. THE CURRENT PATIENT OUTCOME AND CHANCES OF THE PATIENT HAVING PERMANENT DAMAGE OF SCARRING IS UNKNOWN. THE PATIENT NEVER RETURNED TO THE CLINIC FOR A FOLLOW UP; HOWEVER, IT WAS LATER REPORTED THAT THERE WAS AN INCIDENT REGARDING A BURN OF THE FACE THAT WAS PUBLISHED ON A PUBLIC COMMUNITY WEBSITE. NO PATIENT PICTURES HAVE BEEN MADE AVAILABLE FOR EVALUATION. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED, AND IT IS UNKNOWN IF THE PATIENT HAS UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN NINETY DAYS PRIOR. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND THE USER DOES NOT RECALL SEEING ANYTHING TOO ABNORMAL. THE TREATMENT TIP SURFACE WAS NOT REINSPECTED DURING THE PROCEDURE; HOWEVER, IT WAS NOTICED THAT AFTER COMPLETING THE TREATMENT, THE TIP WAS INDENTED. THE HIGHEST ENERGY BEING USED WAS 3 MJ. NO SYSTEM ERRORS OR ANYTHING OUT OF THE ORDINARY WAS NOTICED DURING THE PROCED

  Patient problems: Burn(s); Erythema

  MAUDE report 19787073 ↗
• InjuryJul 18, 2024Improper or Incorrect Procedure or Method; Excessive Cooling; Excessive Heating; Improper or Incorrect Procedure or Method; Excessive Cooling; Excessive Heating

  A USER FACILITY REPORTED BURNS, BLISTERS, AND ERYTHEMA ON BOTH SIDES OF THE LATERAL NECK IMMEDIATELY AFTER A THERMAGE FLX TREATMENT OF THE FACE AND NECK. THE INCIDENT OCCURRED AFTER 200 SHOTS WITH THE HIGHEST ENERGY BEING 3 MJ ON THE FACE AND 1.5 MJ ON THE NECK. IT WAS NOTICED THAT DURING THE PROCEDURE THAT ¿TIP TOO WARM¿ AND ¿TIP TOO COLD¿ ERROR MESSAGES OCCURRED. IT WAS REPORTED THAT CRYOGEN AND APPROXIMATELY 30ML OF COUPLING FLUID WAS USED. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND APPROXIMATELY EVERY 200 PULSES THROUGHOUT THE TREATMENT, AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE TIP USED DURING THIS TREATMENT WAS NOT USED ON USED ON OTHER PATIENTS. THE TIP WAS NOT KEPT BY THE USER FACILITY; THEREFORE, IT CANNOT BE RETURNED FOR EVALUATION. THE PATIENT WAS REPORTEDLY PLACED UNDER ANESTHESIA FOR THE THERMAGE TREATMENT. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN NINETY DAYS PRIOR TO THE TREATMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAS NOT HAD PRIOR AESTHETIC TREATMENTS. THE PATIENT REPORTEDLY EXPERIENCED 3RD DEGR

  Patient problems: Blister; Erythema; Full thickness (Third Degree) Burn

  MAUDE report 19772639 ↗
• InjuryJul 12, 2024Improper or Incorrect Procedure or Method; Excessive Cooling; Excessive Heating; Improper or Incorrect Procedure or Method; Excessive Cooling; Excessive Heating

  A USER FACILITY REPORTED TWO SECOND DEGREE PATIENT BURNS/MINOR BLISTERS ON THE LEFT CHEEK AFTER A THERMAGE FLX FACIAL TREATMENT. THE PATIENT WAS PLACED UNDER INTRAVENOUS PROPOFOL DURING THE TREATMENT. THE ISSUE OCCURRED AFTER 800 REPS. THE HIGHEST ENERGY LEVEL USED WAS 4. SEVERAL ERRORS REPORTEDLY OCCURRED DURING THE TREATMENT: TIP TOO WARM, INSUFFICIENT FORCE ERROR, TIP LIFTED PREMATURELY, AND TIP TOO COLD. SOLTA CRYOGEN AND 40-50 ML OF SOLTA COUPLING FLUID WERE USED DURING THE TREATMENT. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND EVERY 50-100 PULSES, WITH NO ANOMALIES NOTED. THIS TREATMENT WAS THE INITIAL USE OF THE TREATMENT TIP, WHICH WAS NOT RETAINED FOR EVALUATION. THREAD LIFTING THERAPY WAS ALSO BEING PERFORMED IN THE TREATMENT AREA AT THE SAME TIME AS THE THERMAGE TREATMENT. THE PATIENT HAS A HISTORY OF AESTHETIC TREATMENTS TO THE FACE, YET NO OTHER TREATMENTS HAD BEEN PERFORMED WITHIN THE PREVIOUS NINETY DAYS. SULFADIAZINE SILVER WAS USED TO TREAT THE AFFECTED AREA. THE PATIENT APPLIED HEAT OR ICE POST TREATMENT. THE PATIENT USED DRESSING, HYPERBARIC OXYGEN, AND GROWTH FACTOR THERAPY ON THE BURNED AREAS. THE SOLTA MEDICAL REVIEWER REVIEWED PROVIDED PHOTOS. BURNED ARE

  Patient problems: Blister; Hyperpigmentation; Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 19733820 ↗
• InjuryJul 1, 2024Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED 2ND DEGREE BURNS AND BLISTERS ON BOTH OF THEIR CHEEKS FOLLOWING A THERMAGE FLX TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND 50ML OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 5.5. THE PATIENT HAD RECEIVED TREATMENT TO THEIR ENTIRE FACE AND PRIOR TO THE BEGINNING OF THE TREATMENT, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE SEVERAL ERRORS HAD OCCURRED RELATED TO LIFTING THE TIP PREMATURELY FROM THE SKIN, APPLYING INSUFFICIENT FORCE, AND THE TIP TEMPERATURE WAS TOO HIGH. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO AND DURING THE PROCEDURE, EVERY 150 PULSES, WITH NO DISCREPANCIES OBSERVED. THE DAY FOLLOWING THE TREATMENT THE PATIENT HAD OBSERVED BURNS AND BLISTERS ON BOTH OF THEIR CHEEKS. THE PATIENT WAS PRESCRIBED PBF SILZINE CREAM. THEIR CURRENT STATUS, AS REPORTED BY THE CUSTOMER, IS IT SEEMS THE BLISTERS ARE RESOLVED AND NO PERMANENT SCARRING IS EXPECTED. THE PATIENT HAD NOT RECEIVED ANY OTHER TREATMENT IN THE SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. A SOLTA MEDICAL REVIEWER EXAMINED INITIAL PICTURES OF THE PATIENT.

  Patient problems: Blister; Erythema; Partial thickness (Second Degree) Burn; Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 19651927 ↗
• InjuryJun 11, 2024Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION WAS RECEIVED ON THE PATIENT'S STATUS. THE PATIENT REPORTED THEY ARE STILL DEALING WITH PIGMENTATION ON THE NECK AND ARE CONSIDERING LASER TREATMENT TO HELP LIGHTEN THE PIGMENTATION.

  Patient problems: Erythema; Itching Sensation; Pain; Rash; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 19515669 ↗
• InjuryMay 24, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT BURNS AND BLISTERS WERE OBSERVED ON THE PATIENT¿S LEFT CHEEK SOON AFTER A THERMAGE FACIAL TREATMENT. THE HIGHEST ENERGY LEVEL USED WAS 3.0. THE PROVIDER USED A METHOD OF STAMPING ONCE, THEN SLIDING THROUGHOUT. GEL COUPLING FLUID (20ML) AND CRYOGEN WERE USED. THE TREATMENT TIP WAS NEW (INITIAL USE) AND WAS INSPECTED PRIOR TO TREATMENT BUT NOT THROUGHOUT. HYDROCORTISONE AND BACITRACIN WERE USED ON THE AFFECTED AREAS. NO OTHER TREATMENTS WERE BEING PERFORMED AT THE SAME TIME. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS OF THE FACE. THE PROVIDED PICTURE WAS REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHO NOTED THAT BLISTERS AND INFLAMMATION WERE VISIBLE ON THE LEFT CHEEK.

  Patient problems: Blister; Burn(s); Skin Inflammation/ Irritation

  MAUDE report 19395498 ↗
• InjuryApr 17, 2024Excessive Heating; Excessive Heating

  INFORMATION CONCERNING THE OUTCOME OF THE PATIENT WAS REQUESTED AND THE CLINIC DECLINED TO PROVIDE ANY INFORMATION RELATED TO THE PATIENT.

  Patient problems: Blister; Burn(s); Localized Skin Lesion

  MAUDE report 19125989 ↗
• InjuryApr 17, 2024Excessive Heating; Excessive Heating

  INFORMATION CONCERNING THE OUTCOME OF THE PATIENT WAS REQUESTED AND THE CLINIC DECLINED TO PROVIDE ANY INFORMATION RELATED TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 19125967 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BLISTER TO THE RIGHT TEMPORAL AREA WITH REDNESS AND SWELLING ON THE LEFT FOREHEAD FOLLOWING A FACIAL THERMAGE FLX PROCEDURE. THE PATIENT RECEIVED ARTIFICIAL SKIN AND AN ICE PACK FOR THE INJURY. IT IS NOTED THAT THE PATIENT DID NOT APPLY ANY OVER THE COUNTER MEDICINE POST TREATMENT. THE CURRENT STATUS IS REPORTED THAT THE BLISTERS ARE RESOLVING. THE OUTCOME NOTED AS NO PERMANENT INJURY EXPECTED: HOWEVER, POST INFLAMMATORY HYPERPIGMENTATION IS EXPECTED. NO PICTURE WAS AVAILABLE FOR REVIEW. THE EXACT LOCATION OF INJURY IS TO THE RIGHT TEMPORAL AREA WITH A 0.5 CM BY 0.5 CM BLISTER & LEFT FOREHEAD (HAIRLINE) 1 CM OF REDNESS. THE NATURE OF THE INJURY IS REPORTED AS A BURN, 1ST DEGREE ¿ SUPERFICIAL REDNESS AND SWELLING, 2ND DEGREE ¿ BLISTER, (MINOR). SUPERFICIAL ANESTHETIC WAS ADMINISTERED TO THE PATIENT PRIOR TO THE TREATMENT AND THE PATIENT WAS ALERT AND ABLE TO PROVIDE FEEDBACK DURING TREATMENT. THE PATIENT'S CURRENT STATUS IS REPORTED THAT THE BLISTERS ARE RESOLVING. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS UNDERGONE SOFWAVE FOREHEAD (100 LINES) I

  Patient problems: Blister; Erythema; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 19032981 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A POSSIBLE SECOND DEGREE BURN TO THE PATIENT'S LEFT JAWLINE FOLLOWING A FACIAL THERMAGE FLX TREATMENT. THE PATIENT WAS TREATED WITH AN ARTIFICIAL SKIN GRAFT AND GIVEN AN ICE PACK. THE PATIENT DID NOT APPLY ANYTHING OVER THE COUNTER AT HOME TO TREAT THE BURN. THE CURRENT STATUS IS REPORTED THAT THE BLISTERS ARE RESOLVING WITH NO PERMANENT SCAR EXPECTED. HOWEVER, IT IS NOTED THAT POST INFLAMMATORY HYPERPIGMENTATION IS EXPECTED. AN AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER AND A LARGE BLISTER IS VISIBLE UNDER THE SKIN GRAFT ON THE JAWLINE. THE PATIENT WAS ADMINISTERED IV ANESTHESIA AND UNABLE TO SUPPLY FEEDBACK DURING THE TREATMENT. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS HAD PRIOR THERMAGE FLX AESTHETIC TREATMENTS ON THIS AREA. THE INCIDENT OCCURRED AT ABOUT 900 REPS. THE HIGHEST ENERGY LEVEL USED WAS 3.5J. NO SYSTEM ERRORS OCCURRED NOR DID ANYTHING OUT OF THE ORDINARY OCCUR DURING TREATMENT. A STAMPING METHOD WAS USED. SOLTA CRYOGEN AND 40 ML OF UNSCENTED C

  Patient problems: Burn(s)

  MAUDE report 19032957 ↗
• InjuryMar 28, 2024Excessive Heating; Excessive Heating

  THE DOCTOR DECLINED TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Burn(s)

  MAUDE report 18991807 ↗