Thermage TTNS3.00E4-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00850608002421), received between Jun 28, 2018 and Mar 5, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Insufficient Cooling; Material Puncture/Hole; Material Deformation

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN ON THEIR FACE FOLLOWING A THERMAGE CPT TREATMENT. DURING THE PROCEDURE THE PROVIDER DELIVERED APPROXIMATELY 896 PULSES WHEN A CRYOGEN ERROR MESSAGE WAS SHOWN ON THE SYSTEM DISPLAY. THE SYSTEM WAS POWERED OFF AND CRYOGEN WAS RESEATED TO CLEAR THE ERROR, BUT THE PROVIDER NOTICED THERE WAS A HOLE IN THE TREATMENT TIP AND THE PATIENT HAD SUSTAINED A BURN INJURY ON THE RIGHT SIDE OF THEIR FACE, SPECIFICALLY ON THE UNDER-EYE AREA EXTENDING FROM THE NOSE/CHEEK REGION TO THE EAR. THE PROVIDER APPLIED ICE AND POLYSPORIN TO THE AFFECTED AREAS. THE PATIENT¿S CURRENT STATUS IS THAT THERE IS PERSISTENT SUBDERMAL DARKENING AND UNEVEN SKIN TEXTURE FOLLOWING PRIOR SCARRING. THE PROVIDER INDICATED THAT WHILE THE CONDITION IS NOT SEVERE, ADDITIONAL INTERVENTION IS NEEDED TO SUPPORT RECOVERY. THE PATIENT DID NOT UNDERGO ANY OTHER TREATMENT ON THE PROCEDURE DATE. THE PATIENT DID RECEIVE A HYRDOFACIAL TREATMENT WITHIN 90 DAYS PRIOR TO THE TREATMENT AND HAD RECEIVED THERMAGE TREATMENT APPROXIMATELY ONE YEAR PRIOR. A SOLTA MEDICAL REVIEWER EXAMINED AN UNDATED PHOTO OF THE PATIENT INJURY. IT WAS OBSERVED IN THE PHOTO THERE WAS DIFFUSE ERYTHEMA, IN

  Patient problems: Burn(s); Erythema; Hyperpigmentation; Scar Tissue; Skin Disorders; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 24526266 ↗
• InjuryFeb 13, 2026Excessive Cooling

  A USER FACILITY REPORTED BLISTERING AND WELTS ON THE LEFT UPPER ABDOMEN OF A PATIENT DURING A THERMAGE CPT TREATMENT. FUCIDIN H WAS RECOMMENDED BY THE SUPERVISING PHYSICIAN AND INITIATED IMMEDIATELY WITH INSTRUCTIONS TO APPLY TWICE DAILY. AS OF ELEVEN DAYS POST TREATMENT, THE EVENT HAS RESULTED IN POST-INFLAMMATORY HYPERPIGMENTATION. DURING THE TREATMENT SESSION THE HANDPIECE (HP) WAS DROPPED. THE TREATMENT TIP WAS SUBSEQUENTLY INSPECTED AND APPEARED TO BE INTACT, WITH NO VISIBLE DAMAGE. TREATMENT WAS THEN RESUMED ON THE ABDOMINAL AREA WHEN THE TECHNICIAN OBSERVED THE DEVELOPMENT OF WELTS AND BLISTERS ON THE PATIENT¿S SKIN. UPON NOTICING THESE FINDINGS, THE TREATMENT WAS IMMEDIATELY DISCONTINUED, AND THE TECHNICIAN DISCARDED THE TREATMENT TIP. NO PATIENT PHOTOGRAPHS WERE AVAILABLE. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. NO PAIN MEDICATION OR ANESTHESIA WAS ADMINISTERED. THE PATIENT DID RECEIVE PRONOX DURING THE TREATMENT. THE INCIDENT OCCURRED AT A LEVEL 2.0-3.0, WITH THE HIGHEST ENERGY LEVEL USED AS 3.0. AN ERROR CODE STATING THAT THE TIP WAS TOO COLD WITH A WARNING INDICATING NOT TO TREAT THE SAME AREA AP

  Patient problems: Blister; Erythema; Hyperpigmentation; Skin Inflammation/ Irritation

  MAUDE report 24339519 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS OF THE LOWER FACE AND NECK APPROXIMATELY ONE DAY AFTER A THERMAGE CPT TREATMENT, AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHICH IDENTIFIED WOUNDS AND SCAB FORMATION PRIMARILY ON ONE SIDE OF THE FACE, WITH A VISIBLE WOUND ON THE NECK AND SMALL SCABS ON THE OPPOSITE SIDE OF THE FACE. THE USER FACILITY REPORTED THAT THE PATIENT IS EXPERIENCING SCARRING, AND PIGMENTATION CHANGES OF THE FACE AND NECK ARE EXPECTED. NO SECONDARY INTERVENTIONS WERE REPORTED. NO SYSTEM ERRORS OR UNUSUAL CONDITIONS WERE OBSERVED DURING THE PROCEDURE. THE HIGHEST ENERGY LEVEL DURING TREATMENT WAS 4.0 MJ USING THE STAMPING METHOD. THE SURFACE OF THE TREATMENT TIP WAS REPORTEDLY NOT INSPECTED PRIOR TO USE, NOR WAS IT INSPECTED DURING THE PROCEDURE. THE USER FACILITY CONFIRMED THE USE OF SOLTA CRYOGEN AND APPROXIMATELY TWO BOTTLES OF UNSCENTED SOLTA COUPLING FLUID. THE PATIENT REPORTEDLY EXPRESSED SATISFACTION WITH THE RESULTS OF A THERMAGE TREATMENT CONDUCTED LAST YEAR. HOWEVER, NO ADDITIONAL DETAILS REGARDING PREVIOUS AESTHETIC PROCEDURES HAVE BEEN PROVIDED. THE USER FACILITY IS UNCERTAIN OF WHAT CAUSED THE BURN. THE PATIENT WAS N

  Patient problems: Burn(s); Scar Tissue; Skin Discoloration

  MAUDE report 23821994 ↗
• InjuryApr 22, 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 SMALL DEPRESSION IN THE LEFT CHEEK AFTER A FULL FACE THERMAGE CPT TREATMENT. IMMEDIATELY AFTER THE TREATMENT, THE PATIENT REPORTED SWELLING OF THE LEFT FACE. AN INDENTATION IN THE LEFT CHEEK AREA WAS NOTED BY THE PATIENT APPROXIMATELY ONE-MONTH POST-TREATMENT. AT A FOLLOW-UP APPOINTMENT APPROXIMATELY 10.5 WEEKS POST-TREATMENT, THE CLINIC ALSO NOTED A SMALL AREA NEAR THE LEFT CHEEK BONE THAT IS DEPRESSED DURING CERTAIN FACIAL MOVEMENTS, SUCH AS SMILING. NO SECONDARY INTERVENTION WAS USED TO TREAT THE CONDITION. IT IS UNCLEAR IF THE INDENTATION WILL BE PERMANENT. THE SOLTA MEDICAL REVIEWER EVALUATED THE PATIENT IMAGES AND NOTED AN INDENTATION THAT IS SMALL AND ONLY NOTICEABLE IN CERTAIN FACIAL EXPRESSIONS. NO PRE-PROCEDURE PHOTOGRAPHS ARE AVAILABLE FOR COMPARISON, MAKING IT DIFFICULT TO ASSESS THE EXTENT OF THE CHANGE RELATIVE TO THE PATIENT'S ORIGINAL APPEARANCE. THE PATIENT WAS ADMINISTERED ADVIL AND TYLENOL PRIOR TO THE TREATMENT. THE HIGHEST ENERGY LEVEL USED WAS 7 (VERY MINIMALLY). NO SYSTEM ERRORS OCCURRED DURING TREATMENT AND NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING TREATMENT. THE TREATMENT TIP WAS INSPECTED PRIOR TO

  Patient problems: Localized Skin Lesion; Swelling/ Edema

  MAUDE report 21885833 ↗
• InjuryMar 12, 2025Unintended Movement; Excessive Heating; Unintended Movement; Excessive Heating

  THOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION OR OUTCOME HAS BEEN RECEIVED.

  Patient problems: Blister; Burn(s); Erythema

  MAUDE report 21590204 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED GRID-LIKE PATTERN SCABBING ON THE LEFT CHEEK AND NECK AREA FOLLOWING A THERMAGE CPT TREATMENT. THERMAGE WAS PERFORMED ON THE PATIENT'S FULL FACE AND NECK NO ISSUES NOTED. THE LEFT FACE HAD BEEN TREATED FIRST. THE DAY FOLLOWING THE TREATMENT THE PATIENT OBSERVED SCABBING ON THE LEFT SIDE OF THEIR FACE AND NECK IN A GRID-LIKE PATTERN. THERE WAS NO INJURY OF THE RIGHT FACE OR RIGHT NECK. IT IS UNKNOWN IF ANY SECONDARY INTERVENTION WAS APPLIED OR PRESCRIBED AFTER THE INJURY WAS REPORTED. THE PATIENT DID NOT RECEIVE ANY OTHER TREATMENT TO THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT DOES RECEIVE THERMAGE TREATMENTS IN THE SAME SYMPTOM AREA EVERY 6 MONTHS FOR THE PAST 5 YEARS ON THE SAME TREATMENT SETTINGS WITH NO HISTORY OF ADVERSE EVENTS. THEIR CURRENT STATUS IS THE INJURY HAS IMPROVED AND THE SKIN IS STILL HEALING. IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. SOLTA MEDICAL BRANDED CRYOGEN AND A ¿GENEROUS¿ AMOUNT OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 2.0. NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED

  Patient problems: Localized Skin Lesion

  MAUDE report 21473149 ↗
• InjuryFeb 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 BURNING SENSATION AND HAD REDNESS AND HYPERPIGMENTATION ON THEIR LEFT CHEEK FOLLOWING A THERMAGE TREATMENT. AFTER THE TREATMENT WAS COMPLETED, IT WAS OBSERVED THE PATIENT HAD WHITE LINES AND DISCOLORATION ON THEIR LEFT CHEEK. AN ICE PACK AND 1% HYDROCORTISONE WERE APPLIED TO THE AFFECTED AREA. A SOLTA MEDICAL REVIEWER EXAMINED PICTURES OF THE PATIENT INJURY. TWO PICTURES OF THE PATIENT'S FACE ON ONE SIDE WERE PROVIDED. THE PICTURES REVEALED A POSSIBLE BURN ON THE LEFT CHEEK AREA. THE PATIENT¿S CURRENT STATUS 18 DAYS POST-PROCEDURE IS THAT THEY ARE IMPROVING, AND PERMANENT DAMAGE IS NOT EXPECTED. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS. SOLTA MEDICAL BRANDED CRYOGEN AND 4/5 OF A BOTTLE OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 4.0. THE PATIENT HAD RECEIVED THERMAGE TREATMENT TO THEIR FACE AND NO SYSTEM ERRORS OCCURRING DURING THE PROCEDURE. THE PROVIDER OBSERVED AFTER 860 PULSES WERE DELIVERED THAT THE TREATED AREA SEEMED TO HEAT UP QUICKLY AND MORE THAN NORMAL REDNESS HAD DEVELOPED. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED, AND IT WAS INSPECTED PRIOR TO USE, AND AGAIN AT 600 PULSES, W

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

  MAUDE report 21316345 ↗
• InjuryFeb 5, 2025Material Integrity Problem; Material Integrity Problem

  THE PATIENT REPORTED HAVING NO FURTHER ISSUES OR CONCERNS. ADDITIONALLY, THE PHYSICIAN INDICATED THAT NO SCARRING WAS EXPECTED. NO TREATMENT BEYOND THE STANDARD OF CARE WAS REPORTED. BASED ON THE NEW INFORMATION, THE SOLTA MEDICAL REVIEWER CONCLUDED THAT THIS EVENT IS NOT A SERIOUS INJURY. THE EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

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

  MAUDE report 21314477 ↗
• InjuryJan 23, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT THEY EXPERIENCED CONJUNCTIVAL CONGESTION AND CONJUNCTIVITIS TO THE RIGHT EYE AFTER A THERMAGE CPT FACE AND NECK PROCEDURE. THE REPORT NOTED THAT A DAY AFTER THE PROCEDURE, THE PATIENT WENT TO AN OPHTHALMIC HOSPITAL FOR TREATMENT. THE PATIENT WAS DIAGNOSED WITH CONJUNCTIVAL CONGESTION AND CONJUNCTIVITIS AND RECEIVED AN EYE RINSE AND WAS PRESCRIBED UNKNOWN EYE DROPS. THE REPORT NOTED THAT OVER TWO DAYS, THE SYMPTOMS HAVE SLIGHTLY IMPROVED AFTER USING THE EYE DROPS. THE PATIENT STATED THAT DURING THE TREATMENT OF THE EYE AREA, NO PROTECTIVE MEASURES WERE PROVIDED (NO EYE SHIELDS WERE USED), AND THE TREATMENT WAS NOT CARRIED OUT ACCORDING TO THE OFFICIAL METHOD BUT WITH A SLIDING METHOD. THE PATIENT ALSO NOTED THAT DURING THE PROCEDURE, THE GEL (LIKELY COUPLING FLUID) GOT INTO THEIR EYES. AFTER THE TREATMENT, THE PATIENT'S EYES FELT STINGING, SORE AND SWOLLEN. THE USER FACILITY WAS CONTACTED AND STATED THAT THE TREATMENT WAS PERFORMED WITH NO COMPLICATION. DURING THE FACIAL ASSESSMENT, THE PATIENT EXPRESSED A DESIRE TO RETAIN HER LOWER EYELID BAGS (UNDER-EYE HOLLOWNESS) BUT WAS ASSURED THAT THE TREATMENT WOULD NOT BE PERFORMED IN THAT AREA. THE FACIAL TREATMENT

  Patient problems: Conjunctivitis; Eye Irritation; Eye Pain

  MAUDE report 21225772 ↗
• MalfunctionJan 23, 2025Material Discolored; Material Discolored

  THE USER FACILITY REPORTED A BLACK DOT ON A THERMAGE CPT TREATMENT TIP AFTER STARTING A TREATMENT. ONCE OBSERVED, THE CUSTOMER DID NOT FEEL COMFORTABLE COMPLETING THE REST OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THE TREATMENT TIP WAS RETURNED TO SOLTA FOR AN EVALUATION AND DIELECTRIC BREAKDOWN WAS OBSERVED; THEREFORE, THIS MEETS THE REPORTABILITY REQUIREMENTS FOR A MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223538 ↗
• InjuryDec 13, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  AVAILABLE INFORMATION WAS RECEIVED AND REVIEWED. IT IS REPORTED THAT THE PATIENT'S SKIN HAS RECOVERED AND THERE WILL BE NO SCARRING. AFTER FURTHER EVALUATION OF THE CASE, REVIEW OF PATIENT IMAGES, AND CONSIDERATION OF THE FULL RECOVERY WITHOUT SCARRING, AND THE NOTED TREATMENT - WHICH DOES NOT EXCEED THE STANDARD OF CARE, THE CASE WAS DOWNGRADED TO "NOT SERIOUS". THEREFORE, THIS CASE NO LONGER MEETS THE REQUIREMENT FOR REPORTING.

  Patient problems: Burn(s); Distress; Erythema; Nodule; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 20930635 ↗
• InjuryAug 27, 2024Material Discolored; Appropriate Device Problem Term/Code Not Available; Material Discolored; Appropriate Device Problem Term/Code Not Available

  A USER FACILITY REPORTED A SEVERE REACTION AND WHAT LOOKS LIKE SOME MINOR BURNS AND CUTS ON THE RIGHT SIDE OF THE FACE 1 DAY POST TREATMENT. THE LEFT SIDE OF THE FACE DIDN'T APPEAR TO HAVE ANY SERIOUS ISSUES AT THE TIME OF THE REPORT. HOWEVER, THE RIGHT SIDE OF THE FACE HAD MORE SERIOUS DAMAGE. SECONDARY INTERVENTION INCLUDED SKINCEUTICAL'S EPIDERMAL REPAIR CREAM AND SKINCEUTICAL'S PHYTO GEL FOR THE PATIENT TO USE. THE REPORT NOTED THAT THERE IS A POSSIBILITY OF A PERMANENT SCAR. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER AND SHOWS ERYTHEMA, BURNED AREAS, AND CUTS ON THE RIGHT SIDE OF THE FACE, NECK, AND FOREHEAD. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS UNDERGONE UNSPECIFIED TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS.THE PATIENT HAS NOT HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. TWO TYLENOL PILLS WERE ADMINISTERED TO THE PATIENT FOR THE TREATMENT. THE HIGHEST ENERGY LEVEL USED: 5.5 MJ. THE TECHNICIAN WHO DID THE TREATMENT DID NOT NOTICE THAT THE TIP HAD A WHITE SPOT IN THE MIDDLE UNTIL THE TREATMENT WAS COMPLETE. A SYSTEM ERROR ALSO OCCURRED AFTER THE CRYOGEN CAN

  Patient problems: Burn(s); Erythema; Hypersensitivity/Allergic reaction; Skin Tears

  MAUDE report 20077952 ↗
• InjuryAug 22, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  A USER FACILITY REPORTED A BLISTER WITH SURROUNDING AREAS OF ERYTHEMA TO THE PATIENT'S SUPRA UMBILICAL AREA CENTER (RIGHT) DURING A THERMAGE CPT TREATMENT. SECONDARY INTERVENTION INCLUDED DIPROGENTA, WITH TOUCHES OF IODINE AND DIPROGENTA ON THE FOLLOWING DAYS. AS OF RECENT, ROSEHIP AND CICALFATE ARE BEING USED. THE PATIENT'S CURRENT STATUS IS REPORTED AS A PAPULAR RAISED LESION WITH HYPERPIGMENTATION OR HYPOPIGMENTATION AS A POSSIBLE OUTCOME; HOWEVER, THAT THE PATIENT IS PROGRESSING WELL. AN AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER AND A RAISED PAPULAR LESION IS VISIBLE. 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. A THERMAGE TREATMENT WAS PERFORMED ON THE ABDOMEN THREE YEAR PRIOR TO THIS EVENT. THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR PLACED UNDER ANESTHESIA. THE INCIDENT OCCUR IS REPORTED TO HAVE OCCURRED AT 400 SHOTS OVER THE PAPULOSE ZONE. THE HIGHEST ENERGY LEVEL USED WAS 3.5MJ. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. HOWEVER, THE U

  Patient problems: Blister; Erythema

  MAUDE report 20030755 ↗
• MalfunctionJul 22, 2024Sparking; Sparking

  UPON EVALUATION OF THE DEVICE, NO DIELECTRIC BREAKDOWN WAS OBSERVED. THIS EVENT NO LONGER MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION PER SOLTA PROCEDURE.

  Patient problems: Blister; Hyperpigmentation

  MAUDE report 19802536 ↗
• MalfunctionJul 22, 2024Sparking; Sparking

  A USER FACILITY REPORTED SPARKS FROM THE TREATMENT TIP DURING A THERMAGE CPT TREATMENT OF THE FACE, NECK, AND EYES. THE PATIENT EXPERIENCED BLISTERS AND REPORTED SMALL, ONE-THIRD PENNY- SIZED AND ICEPICK-SIZED BROWN SHALLOW SCABS OF THE RIGHT AND LEFT CHEEK TWO DAYS AFTER THE TREATMENT. THE PATIENT WAS TREATED WITH A SLIDING METHOD. NO SYSTEM ERRORS AND NOTHING ELSE OUT OF THE ORDINARY WAS OBSERVED DURING TREATMENT. THE HIGHEST ENERGY LEVEL USED WAS 5.5. SOLTA CRYOGEN AND TWO BOTTLES OF COUPLING FLUID WERE USED DURING THE TREATMENT. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND EVERY TEN REPS, WITH NO ANOMALIES NOTED. THIS WAS THE INITIAL USE OF THE TREATMENT TIP. NO OTHER TREATMENTS WERE BEING PERFORMED IN THE AFFECTED AREA AT THE TIME OF THE THERMAGE CPT TREATMENT AND THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS OF THE AREA. NO SECONDARY INTERVENTION WAS USED FOR THE AFFECTED AREAS, AS THE PATIENT DID NOT HAVE ANY SYMPTOMS THE DAY OF THE TREATMENT. THE PATIENT¿S BLISTERS HAVE PEELED OFF WITH RED STAINS REMAINING. NO PERMANENT DAMAGE OR SCARRING IS EXPECTED. AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. SMALL SCABS ARE VISIBLE ON ONE SIDE OF THE PATIENT'

  Patient problems: Blister

  MAUDE report 19796201 ↗
• MalfunctionJul 11, 2024Sparking; Sparking

  CLARIFICATION TO INITIAL SUBMISSION: THE SCABS WERE REPORTEDLY A RESULT OF BLISTERS THAT OCCURRED FROM THE TREATMENT.

  Patient problems: Blister

  MAUDE report 19727320 ↗
• MalfunctionJun 21, 2024Material Discolored; Material Discolored

  A USER FACILITY REPORTED A BLACK SPOT ON THE THERMAGE CPT TIP DURING TREATMENT WITH 828 PULSES REMAINING. THE TIP WAS IMMEDIATELY CHANGED, AND THE PATIENT CHECKED FOR ANY CONSEQUENCE. THERE WAS NO PATIENT INJURY. THE TIP WAS RETURNED AND EVALUATED BY SERVICE TO WHICH DIELECTRIC BREAKDOWN WAS OBSERVED. THEREFORE, THIS CASE MEETS THE CRITERIA FOR REPORTING A MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584116 ↗
• InjuryMay 23, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED EXPERIENCING BURNS ON HER FACE AND NECK FROM AN UNKNOWN (CPT OR FLX) THERMAGE TREATMENT TO THE FACE AND NECK. SOME OF THE BURNS HAVE BEEN REPORTEDLY CLASSIFIED AS SECOND DEGREE AND BEDSORES. HER HUSBAND, ACTING AS HER ATTORNEY, HAS STATED THAT THERE WILL BE NO FURTHER INFORMATION PROVIDED. THEY DECLINED TO PROVIDE EVENT INFORMATION, THE SPECIFIC DEVICE USED, AND THE NAME OF THE CLINIC.

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

  MAUDE report 19384899 ↗
• MalfunctionMay 22, 2024Material Deformation; Material Deformation

  A USER FACILITY REPORTED A TINY DEFECT ON A THERMAGE CPT TIP WHILE THE PATIENT EXPERIENCED EXCESSIVE ERYTHEMA AND HEAT ON THEIR FOREHEAD NEAR THE END OF TREATMENT. THE REPORT NOTED THAT THE EVENT DID NOT CAUSE ANY INJURY TO THE PATIENT. NO TREATMENT WAS NEEDED. THE CURRENT STATUS WAS REPORTED THAT THE PATIENT IS FINE WITH NO PERMANENT DAMAGE EXPECTED. A MEDICAL REVIEW FOUND THAT THIS EVENT WAS NOT A SERIOUS INJURY. AS SUCH, THIS EVENT DOES NOT MEET REPORTABILITY REQUIREMENTS AS A SERIOUS INJURY. THE PATIENT WAS ADMINISTERED 75MG DEMEROL + 50MG GRAVOL INTRAMUSCULAR LEFT DORSOGLUTEAL, WHICH WAS WELL-TOLERATED, PRIOR TO THE TREATMENT. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE THE SYMPTOMS WERE REPORTED. THERE WERE 115 PULSES LEFT ON THE TIP WHEN THE EVENT OCCURRED. THE HIGHEST ENERGY LEVEL USED WAS 2.5-3.0 MJ. NO SYSTEM ERRORS OCCURRED BUT THE PATIENT MENTIONED THE TIP FELT HOT SO THE PROVIDER INSPECTED THE TIP AND SAW A SMALL HOLE. THE PATIENT WAS TREATED WITH A STAMPING METHOD. BOTH CRYOGEN AND UNSCENTED COUPLING FLUID WERE USED. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND NO DENT OR HOLE WAS VISIBLE PRIOR TO THE TREATMEN

  Patient problems: Erythema

  MAUDE report 19376605 ↗
• InjuryMay 22, 2024Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS PROVIDED BY THE USER FACILITY. THE PATIENT'S PREVIOUS PROBLEM CAUSED SOME AREAS ON HER FACE TO BECOME RED, SWOLLEN AND ITCHY. AFTER THE REDNESS AND SWELLING SUBSIDED, HYPERPIGMENTATION BEGAN TO APPEAR. THIS MADE THE CLIENT FEEL VERY ANXIOUS AND NOT WANTING TO GO OUT TO MEET PEOPLE FOR A FEW DAYS. THE PATIENT WAS GIVEN TREATMENTS SUCH AS: PICOWAY, VBEAM, AND FACIAL TO ENSURE THAT HER FACE RECOVERS. THE PATIENT'S CURRENT STATUS WAS DESCRIBED AS BETTER THAN BEFORE, BUT THERE WERE STILL TRACES OF PIGMENTATION WHEN LOOKING CAREFULLY. THE SKIN EPIDERMIS WAS DAMAGED AND LEFT WITH PIGMENTATION. THE PATIENT WILL BE GIVEN 10 SESSIONS OF ULTRA-PICOSECOND PLUS SAKURA LASER TO REPAIR THE PIGMENTATION. SHE HAS DONE TWO OF THESE TREATMENTS SO FAR AND THERE HAS BEEN A DEFINITE IMPROVEMENT IN PIGMENTATION. NO PHOTOGRAPHS WERE AVAILABLE AS THE GUESTS DO NOT ALLOW IT. NO EYE SHIELD WAS USED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS, NOR HAS THE PATIENT EVER HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. NO SY

  Patient problems: Anxiety; Burn(s); Discomfort; Erythema; Hyperpigmentation; Itching Sensation; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 19376487 ↗
• MalfunctionMay 22, 2024Material Deformation; Material Deformation

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED REDNESS ON THEIR FACE DURING A THERMAGE CPT TREATMENT. THE TIP WAS INSPECTED EVERY 50-60 PULSES AND THE PATIENT STATED THEY COULD ONLY FEEL VIBRATION, NO PAIN OR HEAT. AT SOME POINT DURING THE PROCEDURE A HOLE WAS DISCOVERED IN THE TIP MEMBRANE AND THE PATIENT'S FACE SHOWED MORE REDNESS THAN USUAL. THE PROCEDURE WAS THEN STOPPED. NO OTHER DETAILS WERE PROVIDED ABOUT THE EVENT AND THE PATIENT''S CURRENT STATUS AND OUTCOME IS UNKNOWN. A SOLTA MEDICAL REVIEWER DETERMINED THERE WAS NOT ENOUGH INFORMATION TO SUGGEST A SERIOUS INJURY HAD OCCURRED. THE TIP WAS RETURNED FOR EVALUATION AND SOLTA SERVICE DEPOT OBSERVED DIELECTRIC BREAKDOWN IN THE TIP MEMBRANE. THIS EVENT MEETS REPORTABILITY REQUIREMENTS AS IT IS A REPORTABLE MALFUNCTION PER SOLTA PROCEDURE.

  Patient problems: Erythema

  MAUDE report 19376300 ↗
• InjuryMay 9, 2024Material Deformation; Material Deformation

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN ON THEIR CHEEK FOLLOWING A THERMAGE CPT TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND APPROXIMATELY 2 BOTTLES OF COUPLING FLUID WAS USED WITH THE HIGHEST TREATMENT LEVEL AT 3.0. THE PATIENT RECEIVED TREATMENT TO THEIR FULL FACE. NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE HOWEVER IT WAS NOTICED VIBRATION FROM THE HANDPIECE WAS NOT WORKING. THIS WAS THE FIRST TIME THE TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO TREATMENT AND EVERY 30 PULSES DURING THE PROCEDURE, WITH NO DISCREPANCIES FOUND. AFTER TREATMENT WAS COMPLETED, IT WAS OBSERVED THERE WAS A SMALL HOLE IN THE TIP MEMBRANE. THEY ALSO FOUND THE PATIENT HAD THE START OF HYPERPIGMENTATION ON ONE SIDE OF THEIR FACE WHICH LATER TURNED INTO A BURN. THE PATIENT DID NOT RECEIVE ANY OTHER TREATMENT IN THE SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THEY DID REPORTEDLY HAVE TREATMENT IN THE SAME SYMPTOM AREA IN THE PREVIOUS YEAR. THE PATIENT WAS PRESCRIBED BACTROBAN ANTIBIOTIC CREAM TO BE APPLIED TWICE A DAY, PRE-POST 1 CREAM, FNL SUN CREAM AND RETINOL TO BE APPLIED AT THE END OF IF THERE IS STILL HYPERPIGMENTATION. THE PATIENT''S CURRENT STATUS IS

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

  MAUDE report 19281576 ↗
• MalfunctionApr 25, 2024Material Puncture/Hole; Material Puncture/Hole

  A USER FACILITY REPORTED PATENT REDNESS AND A BURN, AND A HOLE IN THE THERMAGE CPT TIP AFTER A TREATMENT. THE AESTHETICIAN NOTICED AFTER THE CONCLUSION OF TREATMENT THAT HER PATIENT'S TREATED AREA HAD PERSISTENT REDNESS. THE AESTHETICIAN THEN FOUND A HOLE IN THE TIP MEMBRANE, BUT NO HOLE HAD BEEN SEEN ON THE TIP SURFACE BEFORE AND DURING THE TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. ERYTHEMA AND INFLAMMATION WERE VISIBLE ON BOTH SIDES OF THE PATIENT'S FACE, WITH ONE SIDE MORE THAN THE OTHER SIDE. NO BLISTER WAS SEEN. IT WAS LATER REPORTED THAT UPON FOLLOW-UP WITH THE PATIENT, THE EVENT WAS RESOLVED WITHOUT ANY PERMANENT SCAR. THE PATIENT HAD BEEN TREATED WITH A COOLING ICE PACK AND HYDROCORTISONE. THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR PLACED UNDER ANESTHESIA. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN 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 HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA TWO YEARS AGO. THE HIGHEST ENERGY LEVEL USED WAS 2.5 MJ THEN 4 MJ. NO SYSTEM ERRORS OCCURRED, NOR WAS NOTICE ANYTHING OUT

  Patient problems: Burn(s); Erythema

  MAUDE report 19188778 ↗
• MalfunctionApr 24, 2024Material Deformation; Material Deformation

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED REDNESS AND A SCRATCH ON THEIR FACE FOLLOWING A THERMAGE CPT TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND APPROXIMATELY 4 BOTTLES OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 3.5. THE PATIENT RECEIVED TREATMENT TO THEIR FULL FACE. NO SYSTEM ERRORS HAD OCCURRED HOWEVER DURING THE PROCEDURE, WITH 400 PULSES LEFT, IT WAS NOTICED THERE WAS A BLACK SPOT ON THE TIP MEMBRANE. THE PATIENT¿S FACE WAS EXAMINED AT THE TIME AND SOME REDNESS WAS FOUND ON THE RIGHT SIDE OF THEIR FACE. THE TIP WAS REPLACED WITH ANOTHER TIP TO FINISH THE PROCEDURE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED, AND IT WAS INSPECTED PRIOR TO USE AND EVERY 10 PULSES WITH NO PROBLEMS FOUND, UNTIL THE BLACK SPOT WAS DISCOVERED. THE FOLLOWING DAY AFTER TREATMENT, THERE WAS A SCRATCH IN THE AREA ON THE PATIENT¿S FACE WHERE THE REDNESS WAS OBSERVED. THERE WAS NO SECONDARY INTERVENTION USED TO TREAT THE INJURY. THERE WERE NO OTHER TREATMENTS PERFORMED IN THE SYMPTOM AREA ON THE PROCEDURE DAY OR WITHIN 30 DAYS PRIOR. A SOLTA MEDICAL REVIEWER EXAMINED THE PATIENT PHOTOS AND SAW ERYTHEMA ON THE CHEEK AREA WITH THREE TO FOUR SUPERFICIAL WOUNDS. THE

  Patient problems: Erythema; Skin Tears

  MAUDE report 19177180 ↗
• InjuryApr 17, 2024Dent in Material; Dent in Material

  THE USER FACILITY REPORTS THAT THE PATIENT IS STILL BEING TREATED BY THE PROVIDER AND THAT THE PATIENT WILL HAVE SCARRING.

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

  MAUDE report 19125915 ↗