ThermageRecalls & reported problems across all models

We found 5 models of Thermage by Solta Medical in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Mar 5, 2026 — classified as 32 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Sparking” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Thermage recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 16, 2023Class IIOpen, Classified

   A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

   Z-1354-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported Thermage problems

Thermage models

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

• Thermage TG-2B

  Massager, Therapeutic, Electric
  1 recall0 reports
• Thermage TTNS3.00E4-1200

  Massager, Therapeutic, Electric
  30 reports
• Thermage TTNS3.00E4-900

  Massager, Therapeutic, Electric
  9 reports
• Thermage TTNS0.25NB1-450

  Massager, Therapeutic, Electric
  5 reports
• Thermage TH-4R

  Electrosurgical, Cutting & Coagulation & Accessories
  2 reports

Recent Thermage adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT THEY HAD RECEIVED THERMAGE CPT TREATMENT AT A USER FACILITY AND EXPERIENCED SECOND-DEGREE BURNS AND BLISTERS ON THEIR UPPER AND LOWER EYELID AREAS ON BOTH EYES. PRIOR TO TREATMENT, THE PHYSICIAN SUSPECTED XANTHELASMA IN THE RIGHT UPPER EYELID REGION. THE PATIENT HAD RECEIVED PREVIOUS AESTHETIC TREATMENTS AND PERIOCULAR COSMETIC PROCEDURES IN THE SAME TREATMENT AREAS, INCLUDING FILLER INJECTIONS (AVELANE) IN THE LOWER EYELID WHICH RESULTED IN VASCULAR OCCLUSION AND BRUISING OF THE LEFT EYE AT THE TIME. THE PATIENT ALSO RECEIVED ROUTINE RADIO-FREQUENCY BASED SKIN TIGHTENING TREATMENTS. DUE TO THE PATIENT¿S HISTORY, THE PHYSICIAN TOOK A CAUTIOUS TREATMENT APPROACH DURING THE THERMAGE CPT TREATMENT. INITIAL EYE ENERGY WAS SET AT 2.0. ENERGY SETTINGS RANGED FROM 2.5¿3.5 FOR THE UPPER EYELID, 2.5¿3.0 FOR THE LOWER EYELID, AND 1.5¿2.0 FOR THE MEDIAL CANTHUS AND OTHER SENSITIVE AREAS. APPROXIMATELY 225 PULSES WERE DELIVERED TO EACH EYE AREA WITH 150-160 PULSES DELIVERED TO THE UPPER EYE LID AREAS. TREATMENT OF THE RIGHT EYE WAS COMPLETED PRIOR TO INITIATION OF TREATMENT ON THE LEFT EYE. NO ABNORMALITIES WERE OBSERVED BY THE PHYSICIAN DURING TREATMENT. THE PATIENT RE

  Patient problems: Blister; Erythema; Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 24162045 ↗
• 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 ↗
• InjurySep 26, 2025Energy Output Problem; Energy Output Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A SECOND-DEGREE BURN INVOLVING THE UPPER AND LOWER EYELIDS FOLLOWING A THERMAGE CPT EYE PROCEDURE. A SUPERFICIAL ANESTHETIC CREAM, SINCAINE 5%, WAS APPLIED PRIOR TO THE BEGINNING OF THE TREATMENT, HOWEVER THE PATIENT REPORTEDLY WAS ALERT AND ABLE TO PROVIDE FEEDBACK DURING THE PROCEDURE. EYE SHIELDS WERE PLACED IN BOTH EYES, AND THE PATIENT WAS GIVEN ANESTHETIC EYE DROPS. DURING TREATMENT AT APPROXIMATELY 100-125 PULSES, THE PROVIDER OBSERVED THE PATIENT¿S SKIN WAS VERY RED BUT THE PATIENT ADVISED THEM THEIR SKIN TURNS RED EASILY. THE PATIENT RECEIVED TOPICAL OINTMENT, HYPERBARIC OXYGEN THERAPY, AND PICOSECOND LASER TREATMENT FOR THE INJURY. ADDITIONALLY, THE PATIENT APPLIED SILVERZINE CREAM AND ICE AT HOME. THE PATIENT¿S STATUS IS THE BLISTER HAD RUPTURED, HOWEVER, IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. THE PROVIDER STATED THE CASE HAD BEEN HANDED OVER TO THEIR INSURANCE COMPANY AND THEY DO NOT WISH TO COMMENT ANY FURTHER ON THE PATIENT¿S RECOVERY STATUS. NO OTHER TREATMENTS WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT HAD RECEIVED AN UNKNOWN AESTHETI

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

  MAUDE report 23157660 ↗
• MalfunctionJul 29, 2025Sparking; Excessive Heating; Sparking; Excessive Heating

  THE USER FACILITY REPORTED A MAXIMUM TEMPERATURE REACHED EVENT CODE AND A FLASHING LIGHT THAT APPEARED AT THE END OF THE TREATMENT TIP AFTER STARTING A THERMAGE CPT TREATMENT. THERE WAS NO INJURY TO THE PATIENT, THE PROCEDURE WAS RESUMED AFTER REMOVING THE AFFECTED TREATMENT TIP AND PLACING A NEW ONE. 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 22654515 ↗
• InjuryJun 16, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED A BLISTER ON THE LEFT SIDE OF THE FOREHEAD A DAY AFTER RECEIVING A THERMAGE CPT TREATMENT OF THE FACE AND NECK. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WITH NITROUS OXIDE TO COMPLETE THE TREATMENT. NO SECONDARY INTERVENTIONS WERE PROVIDED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT¿S CURRENT STATUS AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. THE UNUSED TREATMENT TIP WAS NOT INSPECTED PRIOR TO STARTING OR THROUGHOUT THE PROCEDURE. ACCORDING TO THE REPORTER, DURING THE TREATMENT TWO ERROR MESSAGES WERE RECEIVED INDICATING THAT TUNING WAS NEEDED. THE HIGHEST ENERGY USED WAS 3MJ, USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND COUPLING FLUID TO COMPLETE THE TREATMENT; A GEL APPLICATION WAS APPLIED PER ROW. 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. NO ADDITIONAL INFORMATION IS ABLE TO BE RECEIVED FROM THE PATIENT, AS THE CLINIC HAS BEEN UNABLE TO CONTACT THEM. NO PATIENT PHOTOS ARE AVAILABLE TO BE REVIEWED. THE TREATMENT TIP WAS DISCARDED BY THE USER FACILITY; THEREFORE

  Patient problems: Blister

  MAUDE report 22216591 ↗
• InjuryJun 16, 2025Misconnection; Misconnection

  THE USER FACILITY REPORTED A BLISTER ON THE LEFT CHEEK THAT WAS NOTICED THE DAY AFTER RECEIVING A THERMAGE CPT TREATMENT OF THE CHEEKS, CHIN, AND FOREHEAD. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WITH NITROUS OXIDE TO COMPLETE THE TREATMENT. NO SECONDARY INTERVENTIONS WERE PROVIDED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT¿S CURRENT STATUS AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. THE UNUSED TREATMENT TIP WAS NOT INSPECTED PRIOR TO STARTING OR THROUGHOUT THE PROCEDURE; DURING THE PROCEDURE A, "PLEASE CHECK THE CONNECTION BETWEEN THE PAD AND THE CARTRIDGE¿ ERROR MESSAGE WAS PROMPTED. IT IS UNKNOWN DURING WHAT REP THE ERROR WAS DISPLAYED. THE HIGHEST ENERGY USED WAS 3MJ, USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND APPROXIMATELY HALF A BOTTLE OF SOLTA COUPLING FLUID TO COMPLETE THE TREATMENT. THE PATIENT HAS A HISTORY OF UNDERGOING UNSPECIFIED THERMAGE TREATMENTS IN THE SAME SYMPTOM AREA; HOWEVER, THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. NO ADDITIONAL INFORMATION IS ABLE TO BE RECEIVED FROM THE PATIENT, AS THE CLINIC HAS BEEN UNABLE TO CONTACT

  Patient problems: Blister

  MAUDE report 22216578 ↗
• 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 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Discolored

  A USER FACILITY REPORTED THAT THERE WAS A DARK SPOT ON THE THERMAGE CPT TIP MEMBRANE FOUND DURING A TREATMENT. A REPLACEMENT TIP WAS USED FOR THE REMAINDER OF THE PATIENT TREATMENT AND THE DAMAGED TIP WAS RETURNED FOR EVALUATION. NO DETAILS WERE PROVIDED FOR THE PATIENT TREATMENT AND THERE WAS NO INJURY REPORTED. DEPOT EVALUATED THE TREATMENT TIP AND CONFIRMED THE DARK SPOT WAS DIELECTRIC BREAKDOWN OF THE TIP MEMBRANE. THIS EVENT MEETS REPORTABILITY REQUIREMENTS AS IT IS A REPORTABLE MALFUNCTION PER SOLTA PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256358 ↗
• 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 ↗

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