THERMAGE FLXRecalls & reported problems across all models

We found 8 models of THERMAGE FLX by Solta Medical in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2023 and Aug 19, 2026 — classified as 63 injuries, 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported THERMAGE FLX problems

THERMAGE FLX models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• THERMAGE FLX TT4.00F6-900

  Massager, Therapeutic, Electric
  27 reports
• THERMAGE FLX TT0.25F6-450

  Massager, Therapeutic, Electric
  13 reports
• THERMAGE FLX TT4.00F6-600

  Massager, Therapeutic, Electric
  8 reports
• THERMAGE FLX TT16.00F6-500

  Massager, Therapeutic, Electric
  6 reports
• THERMAGE FLX TH-6

  Massager, Therapeutic, Electric
  3 reports
• THERMAGE FLX TR-4

  Massager, Therapeutic, Electric
  3 reports
• THERMAGE FLX TT0.25F6-225

  Massager, Therapeutic, Electric
  3 reports
• THERMAGE FLX TG-3A

  Massager, Therapeutic, Electric
  1 report

Recent THERMAGE FLX adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 10, 2026Noise, Audible

  A USER FACILITY REPORTED THAT A PATIENT PRESENTED APPROXIMATELY FOUR AND A HALF WEEKS AFTER A THERMAGE FLX EYE TREATMENT PERFORMED BY ANOTHER PHYSICIAN, AT WHICH TIME POST-INFLAMMATORY HYPERPIGMENTATION OF THE LEFT LOWER EYELID WAS OBSERVED. THE PATIENT ALSO REPORTED EXPERIENCING REDNESS, SWELLING, AND SIGNIFICANT PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. IMMEDIATELY AFTER TREATMENT, SECONDARY INTERVENTION INCLUDED APPLICATION OF AN ICE PACK TO THE AFFECTED AREA. A SKIN BOOSTER TREATMENT WAS PERFORMED ON THE DAY THE HYPERPIGMENTATION WAS IDENTIFIED FOUR AND A HALF WEEKS POST-TREATMENT. AT APPROXIMATELY THREE AND A HALF MONTHS POST-PROCEDURE, THE PATIENT¿S CONDITION WAS REPORTED TO BE IMPROVED; HOWEVER, RESIDUAL HYPERPIGMENTATION REMAINED, AND PERMANENT DAMAGE OR SCARRING MAY BE EXPECTED. ALTHOUGH IMPROVEMENT WAS NOTED, THE PRESENCE OF RESIDUAL HYPERPIGMENTATION CLASSIFIES THE EVENT AS SERIOUS AND MEETING REPORTABILITY REQUIREMENTS. AN AVAILABLE PHOTOGRAPH WAS REVIEWED BY THE SOLTA MEDICAL REVIEWER. THE IMAGE SHOWED A LOCALIZED HYPERPIGMENTED LESION IN THE LEFT INFRAORBITAL REGION, JUST INFERIOR TO THE LOWER EYELID, MEASURING APPROXIMATELY 5¿8 MM IN DIAMETER, WITH MILD SURROUNDING E

  Patient problems: Erythema; Hyperpigmentation; Localized Skin Lesion; Pain; Swelling/ Edema

  MAUDE report 24841815 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A LOCALIZED SKIN DEPRESSION ON THE PATIENT'S CHEEK APPROXIMATELY 10 WEEKS POST THERMAGE FLX TREATMENT. THE PROCEDURE REPORTEDLY INCLUDED ENERGY-BASED SKIN TIGHTENING CONSISTENT WITH THERMAGE TREATMENT TO THE FACIAL REGION. APPROXIMATELY 10 WEEKS POST-PROCEDURE, THE PATIENT CONTACTED THE CLINIC TO REPORT A VISIBLE CONTOUR CHANGE IN THE TREATED CHEEK AREA. THE PATIENT DESCRIBED A LOCALIZED DEPRESSION AT THE PRIOR TREATMENT SITE. AT FOLLOW-UP EVALUATION, A LOCALIZED SKIN DEPRESSION WAS OBSERVED IN THE CHEEK REGION CORRESPONDING TO THE AREA OF TREATMENT. NO SECONDARY INTERVENTIONS HAD BEEN INITIATED AT THE TIME OF REPORTING. THE CURRENT STATUS REMAINS ONGOING AT LAST FOLLOW-UP, WITH PERSISTENCE OF THE LOCALIZED CONTOUR DEFECT. THERE IS A POSSIBILITY OF PERMANENT COSMETIC CHANGE OR SCARRING. TWO SUBMITTED IMAGES WERE REVIEWED BY THE MEDICAL REVIEWER OVERALL, THE PHOTOGRAPHIC FINDINGS ARE CONSISTENT WITH LOCALIZED SOFT TISSUE ATROPHY OR CONTOUR DEFORMITY - SOFT TISSUE VOLUME LOSS OR FOCAL SUBCUTANEOUS ATROPHY. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREA

  Patient problems: Atrophy

  MAUDE report 24695113 ↗
• 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 20, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT HAD RECEIVED THERMAGE FLX EYE TREATMENT AND EXPERIENCED BURNS ON BOTH OF THEIR UPPER AND LOWER EYELIDS FOLLOWING THE PROCEDURE. THE PATIENT REPORTED THE INJURY TO THE CLINIC THREE DAYS POST-PROCEDURE. NO SECONDARY MEDICAL INTERVENTION WAS REPORTED. THE PATIENT¿S STATUS IS THEY HAVE A BURN INJURY ON BOTH UPPER AND LOWER EYELIDS AND THERE IS A POSSIBILITY OF PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT DOES NOT HAVE ANY HISTORY OF PREVIOUS AESTHETIC TREATMENTS IN THE SYMPTOM AREA. A SOLTA MEDICAL REVIEWER EXAMINED AN IMAGE OF THE PATIENT INJURY. BILATERAL INVOLVEMENT OF THE UPPER AND LOWER EYELIDS WAS VISIBLE. OBSERVATION FINDINGS INCLUDED ERYTHEMA OF THE UPPER EYELIDS, AREAS OF SUPERFICIAL CRUSTING ALONG THE EYELID MARGINS, AND PATCHY HYPERPIGMENTATION IN THE PERIORBITAL REGIONS. MILD EYELID EDEMA IS ALSO SUSPECTED. THE MEDICAL REVIEWER COULD NOT DETERMINE HEALING PROGRESSION FROM THE IMAGE HOWEVER SUSPECTED THERE WAS A POTENTIAL RISK FOR POST-INFLAMMATORY PIGMENTARY ALTERATION AND POSSIBLE SCARRING. SOLTA MEDICAL BRANDED CRYOGEN AND 33% BOT

  Patient problems: Burn(s); Dry Skin; Erythema; Hyperpigmentation; Swelling/ Edema

  MAUDE report 24649884 ↗
• MalfunctionMar 19, 2026Degraded; Device Emits Odor

  A USER FACILITY REPORTED BURNS AND BLISTERS OF THE UPPER LEFT EYELID FOLLOWING A THERMAGE FLX EYE. THE TREATING PHYSICIAN ALSO OBSERVED DAMAGE TO THE TREATMENT TIP COATING, INDICATING SUSPECTED DIELECTRIC BREAKDOWN. FOLLOWING THE PROCEDURE, THE PATIENT¿S EYE AREA APPEARED PALE AND SUBSEQUENTLY DEVELOPED BLISTERS. SECONDARY INTERVENTION WAS INITIATED BY APPLYING ICE PACKS AND A MOIST EXPOSED BURN OINTMENT (MEBO). THE PATIENT WAS INSTRUCTED TO CONTINUE TREATMENT AT HOME USING MEBO BURN OINTMENT AND GROWTH FACTOR GEL. AS OF FOUR DAYS POST TREATMENT, THE PATIENT WAS UNDERGOING FOLLOW-UP WITH THE TREATING FACILITY, AND SYMPTOMS HAD NOT FULLY RESOLVED; HOWEVER, NO PERMANENT DAMAGE OR SCARRING IS EXPECTED. AVAILABLE PHOTOGRAPHS WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER AND SHOWED MILD ERYTHEMA WITH MINOR BLISTERS AND ASSOCIATED SMALL CRUSTS. THE MEDICAL REVIEWER CONCLUDED THAT A SERIOUS INJURY DID NOT OCCUR. HOWEVER, THIS EVENT MEETS THE CRITERIA OF A REPORTABLE DEVICE MALFUNCTION DUE TO THE SUSPECTED DIELECTRIC BREAKDOWN OF THE TREATMENT TIP. DIELECTRIC BREAKDOWN OF THE TREATMENT TIP MAY LED TO PATIENT INJURY. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE REGULAR THERMAGE T

  Patient problems: Blister; Burn(s); Burning Sensation; Erythema

  MAUDE report 24639069 ↗
• 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 ↗
• InjuryNov 11, 2025Radiation Output Problem; Radiation Output Problem

  PER THE MOST RECENT FOLLOW-UP, THE TREATING FACILITY INDICATED THAT THERE IS A HIGH LIKELIHOOD OF PERMANENT SCARRING.

  Patient problems: Blister; Burn(s)

  MAUDE report 23525966 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN TO THEIR SUPRAUMBILICAL AREA DURING A THERMAGE FLX BODY TREATMENT. THE PATIENT HAD RECEIVED THERMAGE FLX TREATMENT TO THEIR ABDOMEN AND LEGS. AFTER THE INJURY OCCURRED, THE PATIENT WAS TREATED WITH LA ROCHE-POSAY BRANDED CICAPLAST BALM. THE PATIENT¿S CURRENT STATUS IS THEY ARE HEALING HOWEVER HYPOPIGMENTED SPOTS ARE EXPECTED. THE PATIENT TAKES MAGNESIUM AND HYDROLYZED COLLAGEN, AS WELL AS APPLYING MOISTURIZING CREAM, ON A DAILY BASIS. THE PATIENT HAS NOT RECEIVED ANY OTHER TREATMENT TO THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT HAS NEVER RECEIVED TREATMENT TO THE SAME SYMPTOM AREA IN THEIR PAST HISTORY. A SOLTA MEDICAL REVIEWER EXAMINED TWO IMAGES OF THE PATIENT¿S ABDOMEN. ONE IMAGE SHOWED A BLISTER AROUND THE UMBILICUS, WHILE THE OTHER DEPICTED A SMALL BLISTER WITH SURROUNDING ERYTHEMA. NO DATES WERE PROVIDED FOR THE IMAGES. SOLTA MEDICAL BRANDED CRYOGEN AND 4 BOTTLES OF CRYOGEN WERE USED WITH THE HIGHEST LEVEL OF TREATMENT AT 1.5. THE INJURY REPORTEDLY OCCURRED DURING THE ¿FIRST PASS¿ IN THE ABDOMEN AREA. IT IS NOT KNOWN IF THE PROVIDER USED A STAMPING OR SLIDING METHOD. NO SYSTEM ERR

  Patient problems: Blister; Burn(s); Erythema; Hypopigmentation

  MAUDE report 22979940 ↗
• InjuryAug 29, 2025Noise, Audible; Noise, Audible

  A USER FACILITY REPORTED THAT A BURN TO THE PATIENT'S LEFT EYELID OCCURRED DURING A THERMAGE FLX TREATMENT. REVIEW OF A PATIENT IMAGE BY THE SOLTA MEDICAL REVIEWER PHOTOGRAPH NOTES THAT THERE IS DEMONSTRATED ERYTHEMA, AND A WOUND LOCATED BENEATH ONE EYE. AS OF NEARLY ONE MONTH POST TREATMENT, THE PATIENT IS STILL UNDER TREATMENT AT A BURN HOSPITAL, WITH NOT MUCH IMPROVEMENT NOTED. AS THE BURN OCCURRED IN THE DELICATE PERIOCULAR AREA, A PERMANENT SCAR IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR PLACED UNDER ANESTHESIA. AN EYE SHIELD WAS USED, AND THE TYPE OF EYE SHIELD LUBRICATION IS UNKNOWN. THE INCIDENT OCCURRED AFTER 100 REPS ON THE LEFT PERIORBITAL AREA, TO WHICH A BURNING SOUND "BZZZ" WAS HEARD. THE HIGHEST ENERGY LEVEL USED WAS 2.0. TEMPORARY ERROR MESSAGES WERE REPORTED, BUT THE USER IS NOT SURE ABOUT THE EXACT ERROR TYPE. A STAMPING METHOD WAS USED. 30 ML OF UNSCENTED SOLTA COUPLING FLUID WAS UTILIZED. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND THERE WAS NOTHING TO NOTE. THE TREATMENT TIP SURFACE WAS REINSPECTED DURING THE TREA

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

  MAUDE report 22923607 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT DEVELOPED BLISTERS, REDNESS, AND PAIN ON THE FACE THE DAY AFTER RECEIVING A THERMAGE FLX TREATMENT. IT WAS REPORTED THAT NEOSPORIN, VASELINE, EXTENSIVE MOISTURIZER, A SMALL DOSE OF HYDROCORTISONE 1% CREAM, AND AN UNSPECIFIED NUMBING MEDICATION IS BEING USED FOR THE PATIENT AS A SECONDARY INTERVENTION. AS OF ONE MONTH POST PROCEDURE, THE PATIENT IS STILL RECOVERING, AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. IT WAS CONFIRMED THAT THE PATIENT USES AN UNSPECIFIED TOPICAL CREAM ON A REGULAR BASIS, BUT NOT TAKING ANY OTHER PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS OR SUPPLEMENTS ON A REGULAR BASIS. AVAILABLE PHOTOS FROM TWO DAYS AFTER THE PROCEDURE WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHICH IDENTIFIED THAT BOTH CHEEKS APPEAR TO HAVE BURN INJURIES WITH VISIBLE ERYTHEMA AND INFLAMMATION. THE AFFECTED AREA IS MORE PROMINENT ON ONE SIDE, WHILE THE INVOLVEMENT OF THE OTHER SIDE IS LESS APPARENT DUE TO LIMITED IMAGE CAPTURE. THE SOLTA MEDICAL REVIEWER ALSO ASSESSED PHOTOS THAT WERE REPORTEDLY TAKEN SIXTEEN DAYS AFTER THE PROCEDURE, AND IT WAS IDENTIFIED THAT INFLAMMATION HAS SUBSIDED. MILD ERYTHEMA REMAINS VISIBL

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

  MAUDE report 22796159 ↗
• 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 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO A DISTRIBUTOR THAT A PATIENT SUSTAINED A 1.5 X 1.5 CM SECOND DEGREE BURN TO THE RIGHT MEDIAL UPPER ARM TWO DAYS POST BILATERAL ARMS THERMAGE FLX TREATMENT. AVAILABLE IMAGES OF THE PATIENT¿S INNER UPPER ARM WERE REVIEWED BY THE MEDICAL REVIEWER. SEVERAL UNDATED PHOTOGRAPHS DEPICT A WOUND APPROXIMATELY 1 X 1 INCH IN SIZE, LOCATED ON THE INNER ASPECT OF THE UPPER ARM. THE IMAGES CAPTURE THE WOUND AT VARIOUS STAGES OF THE HEALING PROCESS. EARLY IMAGES SHOW AN OPEN WOUND WITH RAW TISSUE EXPOSURE, WHILE SUBSEQUENT IMAGES DEMONSTRATE PROGRESSIVE IMPROVEMENT WITH FORMATION OF GRANULATION TISSUE AND PARTIAL RE-EPITHELIALIZATION. IN THE LATEST AVAILABLE IMAGES, THE WOUND APPEARS FULLY CLOSED, THOUGH RESIDUAL ERYTHEMA AND MILD LOCALIZED INFLAMMATION ARE STILL PRESENT, INDICATING ONGOING TISSUE REMODELING. THE PATIENT RECEIVED WOUND CARE WITH SILVADENE® (SILVER SULFADIAZINE), AND DRESSING CHANGES EVERY TWO DAYS. THE CURRENT STATUS WAS REPORTED AS STABLE; HOWEVER, THE FINAL OUTCOME REMAINS UNKNOWN. THE PATIENT IS NOT TAKING ANY REGULAR (PRESCRIPTION OR NON-PRESCRIPTION) MEDICATIONS, VITAMINS, OR HERBAL SUPPLEMENTS, NOR IS THE PATIENT USING ANY TOPICAL PRODUCT (BOTH M

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

  MAUDE report 22731651 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO A DISTRIBUTOR THAT A PATIENT EXPERIENCED SEVERE BURNS ON THE RIGHT INNER THIGH, ALONG WITH BURNS ON THE LEFT KNEECAP, ELBOW AND CHIN AREA TWO HOURS POST THERMAGE FLX PROCEDURE. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. THREE PHOTOS TAKEN 7 DAYS POST TREATMENT REVEALED CRUSTED WOUNDS LOCATED ON THE INNER THIGH OF ONE LEG AND THE LATERAL ASPECT OF THE KNEE ON THE OPPOSITE LEG. FOLLOW-UP IMAGING 1 MONTH AND 4 DAYS POST TREATMENT INCLUDED FOUR PHOTOGRAPHS. THESE DEMONSTRATED THAT THE WOUND ON THE LATERAL KNEE HAD HEALED, WITH RESIDUAL POST-INFLAMMATORY HYPERPIGMENTATION. IN CONTRAST, THE WOUNDS ON THE INNER THIGH OF THE CONTRALATERAL LEG HAD NOT FULLY HEALED. WHILE THE CRUSTS WERE NO LONGER PRESENT, THE UNDERLYING SKIN APPEARED ERYTHEMATOUS AND IN THE PROCESS OF RE-EPITHELIALIZATION, INDICATING INCOMPLETE HEALING. INFORMATION PROVIDED DESCRIBES APPROXIMATELY 4¿5 LESIONS, MEASURING 2 X 2 CM AND 1 X 1 CM IN SIZE, DESCRIBED AS SECOND AND THIRD-DEGREE BURNS WITH AREAS OF NECROSIS, LOCATED ON THE RIGHT INNER THIGH. THE PATIENT RECEIVED WOUND CARE, DRESSINGS EVERY 2-3 DAYS WITH 2 SESSIONS OF DEBRIDEMENT, AND A TOPICAL BURN CREAM (PRODUCT NOT SPECIF

  Patient problems: Erythema; Full thickness (Third Degree) Burn; Hyperpigmentation; Necrosis; Partial thickness (Second Degree) Burn

  MAUDE report 22731647 ↗
• 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 ↗

Other Solta Medical products

• Thermage5 models · 46 reports · 1 recall
• VASER6 models · 32 reports