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THERMAGE FLX TT0.25F6-450Recalls & reported problems

Solta Medical · FLX TREATMENT TIP, EYE, 0.25CM2, 450 REP · Class 1

All models of THERMAGE FLX (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
13
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00816995021353), received between Nov 15, 2023 and Apr 10, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (3 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4
  • Noise, Audible3
  • Excessive Heating2
  • Use of Device Problem2
  • Connection Problem1
  • Degraded1
  • Device Emits Odor1
  • Material Protrusion/Extrusion1

Patient problems

  • Erythema10
  • Burn(s)7
  • Blister6
  • Hyperpigmentation5
  • Burning Sensation2
  • Localized Skin Lesion2
  • Partial thickness (Second Degree) Burn2
  • Scar Tissue2

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • 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 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 ↗
  • 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 ↗
  • InjuryJun 11, 2025Material Protrusion/Extrusion; Noise, Audible; Material Protrusion/Extrusion; Noise, Audible

    A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED LARGE BLISTERS AND SECOND-DEGREE BURNS ON THEIR LOWER EYELID FOLLOWING THERMAGE FLX TREATMENT. THE PATIENT RECEIVED THERMAGE FLX TREATMENT FIRST TO THEIR FACE AND THEN THEIR EYE AREAS. ENERGY WAS DELIVERED TO THE PATIENT INITIALLY AT A LEVEL OF 4.0 ON THEIR UPPER EYELID. THE CUSTOMER CONFIRMED WITH THE PATIENT THERE WAS NO PAIN OR BURNING SENSATION AND THEN INCREASED THE ENERGY TO 5.0 FOR THE LOWER EYELID. DURING TREATMENT OF THE LOWER EYELID, THE PATIENT WAS LESS TOLERANT, AND THE ENERGY WAS THEN REDUCED BACK DOWN TO 4.0. AFTER 10 PULSES WERE DELIVERED ON THE LOWER ENERGY, THE CUSTOMER HAD HEARD AN ABNORMAL NOISE AND NOTICED A BULGE ON THE TREATMENT TIP. IT WAS OBSERVED THE PATIENT HAD BEEN BURNED ON THE LOWER EYELID AREA. VISIBLE WHITE SQUARE PATCHES WERE PRESENT ON THEIR LOWER EYELID. TREATMENT WAS STOPPED, AND THE PATIENT WAS GIVEN A COLD COMPRESS AND MEBO BURN OINTMENT. FOLLOWING THE PROCEDURE, THE PATIENT HAD DEVELOPED LARGE BLISTERS AND WAS DIAGNOSED WITH SECOND-DEGREE BURNS ON THEIR LOWER EYELID. THEY WERE THEN PRESCRIBED A BASIC FIBROBLAST GROWTH FACTOR AND COMPOUND SULFADIAZINE GEL. THE PATIENT¿S CURRENT STATUS IS THEIR

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

    MAUDE report 22188019 ↗
  • InjuryMay 13, 2025Power Problem; Power Problem

    THE USER FACILITY PROVIDED AN UPDATE STATING THAT THE BURNS ON THE EYE AREA HAVE NOT FULLY HEALED AND SUGGESTED THAT THERE WILL LIKELY BE SOME PERMANENT SCARRING.

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

    MAUDE report 22011178 ↗
  • InjuryMay 1, 2025Connection Problem; Connection Problem

    A USER FACILITY REPORTED BLISTERING UNDER THE PATIENT'S RIGHT EYE DURING A THERMAGE FLX EYE TREATMENT. THE REPORTER INDICATED THAT THE PATIENT DEVELOPED BLISTERS ON THE RIGHT TEAR TROUGH AND RIGHT UPPER EYELID DURING AN EYE PROCEDURE. THE PATIENT WAS TREATED WITH BACITRACIN OINTMENT AND PROVIDED WITH POST-PROCEDURE CARE INSTRUCTIONS. ON THE DAY OF THE EVENT, THE AFFECTED AREAS WERE DESCRIBED AS HEALING, WITH PERSISTENT ERYTHEMA AND SMALL CENTRAL AREAS OF ULCERATION. THE OVERALL OUTCOME REMAINS UNKNOWN. THE REVIEWED PHOTOGRAPH CONFIRMS VISIBLE ERYTHEMA AND INFLAMMATION ON BOTH CHEEKS, ALONG WITH BLISTERING LOCALIZED TO THE RIGHT INFRAORBITAL REGION AND UPPER EYELID. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS HAD PRIOR AESTHETIC TREATMENTS ON THE FACE APPROXIMATELY 4 YEARS AND 5 MONTHS PRIOR TO THE EVENT. THE PATIENT IS CURRENTLY TAKING SEMAGLUTIDE/PYRIDOXINE 4MG-8 MG/ML MDV (1ML 4MG). THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR PLACED UNDER ANESTHESIA. PLASTIC XS EYE SHIELDS WERE USED WITH

    Patient problems: Blister; Erythema; Skin Inflammation/ Irritation

    MAUDE report 21945565 ↗
  • InjuryAug 6, 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 RADIO-FREQUENCY CORNEAL BURN ON THEIR LEFT EYE FOLLOWING A THERMAGE FLX TREATMENT. PRIOR TO THE PROCEDURE, 3 DROPS OF DOUBLE ANESTHETIC COLIRCUSI WAS ADMINISTERED IN EACH EYE AND RECUGEL WAS PLACED IN THE PERIPHERY AND CENTER OF THE EYE PROTECTORS. THE EYE SHIELD WAS INSERTED IN THE RIGHT EYE WITHOUT ANY PATIENT REPORT OF DISCOMFORT. THE EYE SHIELD WAS THEN PLACED INTO THE PATIENT¿S LEFT EYE, WITHOUT ANY FORCE. THE PATIENT IMMEDIATELY REPORTED DISCOMFORT AND PAIN IN THE AFOREMENTIONED EYE (LEFT EYE), ESPECIALLY IN THE UPPER AREA, INCLUDING A STABBING AND STINGING FEELING THAT WAS NOT PERMANENT BUT RATHER INTERMITTENT. THE PATIENT REPORTED BEING ABLE TO TOLERATE THE DISCOMFORT AND INDICATED THAT THE PROCEDURE SHOULD BE CONTINUED. DURING THE TREATMENT, SHE WAS QUESTIONED AGAIN ABOUT HER CONDITION AND MENTIONED THAT SHE WAS FINE. THE PROCEDURE WAS CARRIED OUT WITHOUT COMPLICATIONS. THE AREA WAS WASHED AND THE EYE SHIELDS WERE REMOVED. DESPITE REMOVAL OF THE EYE SHIELD, THE PATIENT CONTINUED TO SUFFER DISCOMFORT. EYE WASHES WITH 0.9% SALINE SOLUTION WERE PERFORMED FOR AT LEAST 5 TIMES, WITH NO APPARENT IMPROVEMENT. IT WAS ALSO RECOM

    Patient problems: Blurred Vision; Burning Sensation; Discomfort; Excessive Tear Production; Eye Burn; Eye Irritation

    MAUDE report 19921043 ↗
  • InjuryJul 3, 2024Use of Device Problem; Use of Device Problem

    A PATIENT REPORTED BURNS WITH SCABBING TO THE LOWER SIDE EYELID ONE DAY POST A THERMAGE FLX EYE TREATMENT. DURING THE TREATMENT, THE DOCTOR PERFORMED 450 REPS AND USED AN EYE SHIELD WITH THE HIGHEST ENERGY LEVEL OF 3 USED. AN ERROR SOUND WAS HEARD 2-3 TIMES DURING THE TREATMENT, BUT THE TREATMENT WAS ABLE TO BE COMPLETED WITH NO PROBLEMS NOTED. THE DOCTOR WAS UNSURE WHAT ERROR MESSAGE(S) WERE RECEIVED. NO OTHER TREATMENTS BESIDES THERMAGE WERE BEING PERFORMED IN THE SAME SYMPTOM AREA, NOR HAD ANY OTHER TREATMENTS BEEN PERFORMED IN THE SYMPTOM AREA WITHIN THE PRIOR THIRTY DAYS. SOLTA MEDICAL CRYOGEN AND ALMOST 30 ML OF COUPLING FLUID WAS USED DURING THE TREATMENT. THIS WAS THE INITIAL USE OF THE TREATMENT TIP, WHICH WAS INSPECTED PRIOR TO USE AND THROUGHOUT THE TREATMENT WITH NO ANOMALIES NOTED. THE TREATMENT TIP WAS NOT RETAINED FOR EVALUATION. THREE PICTURES LABELED ONE DAY AND TWO DAYS AFTER TREATMENT WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. IT IS NOT CLEAR IF THE PICTURES ARE FROM ONE EYE OR BOTH EYES. BURNED AREAS AND SCABS ARE VISIBLE ON THE LOWER AND UPPER EYELIDS. THE PATIENT WAS TREATED WITH NEODEX (STEROIDS + ANTIBIOTICS) OINTMENT TO PREVENT THE SCABS FROM BECOMING DRY

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

    MAUDE report 19671230 ↗
  • InjuryJun 18, 2024Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating

    A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS TO THEIR UPPER AND LOWER EYELIDS FOLLOWING A THERMAGE FLX TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND A 30ML BOTTLE OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 4.0. PRIOR TO TREATMENT THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE SEVERAL FORCE-RELATED ERRORS OCCURRED AND AN ERROR CODE WITH A MESSAGE WARNING THE TIP WAS TOO WARM. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO USE AND DURING THE PROCEDURE EVERY 150 PULSES, WITH NO DISCREPANCIES OBSERVED. THE FOLLOWING DAY THE PATIENT FOUND BURNS AND BLISTERING ON THEIR UPPER AND LOWER EYELIDS. THEY WERE PRESCRIBED PBF SILZINE CREAM. THE PATIENT¿S CURRENT STATUS IS THAT THE BLISTERS ARE NOT RESOLVING BUT NO PERMANENT SCARRING IS EXPECTED. THE PATIENT DID NOT RECEIVE ANY OTHER TREATMENT IN THE SYMPTOM AREA ON THE PROCEDURE DATE, OR WITHIN 90 DAYS PRIOR. IT IS UNKNOWN IF THE PATIENT EVER HAD RECEIVED TREATMENT IN THE SAME SYMPTOM AREA IN THEIR PAST TREATMENT HISTORY. A SOLTA MEDICAL REVIEWER EXAMINED PICTURES OF THE PATIENT. TWO INITIAL PICTURES WERE PROVIDED. ONE PICTURE SHOWED ERYTHEM

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

    MAUDE report 19561899 ↗
  • InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT RECEIVED TREATMENT FOR THEIR BURNS AND RECOVERED WITH NO PERMANENT DAMAGE OR SCARRING. NO DETAILS OF THE BURN TREATMENT WERE PROVIDED. THE SOLTA MEDICAL REVIEWER DETERMINED THAT NO SERIOUS INJURY HAD OCCURRED. THE EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Patient problems: Burn(s)

    MAUDE report 18944680 ↗
  • InjuryMar 8, 2024Excessive Heating; Excessive Heating

    A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AND REDNESS ON BOTH OF THEIR LOWER EYELIDS FOLLOWING A THERMAGE FLX TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND A SUFFICIENT AMOUNT OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 2.0. THE PATIENT RECEIVED TREATMENT TO THEIR FACE AND EYE AREAS. DURING THE PROCEDURE THE CUSTOMER OBSERVED SOME TIP TOO WARM ERRORS HAD OCCURRED AND REPLACED THE TIP TO RESOLVE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED FOR TREATMENT. IT WAS INSPECTED PRIOR TO USE ON THE PATIENT BUT IT¿S UNKNOWN IF IT WAS INSPECTED AT ANY TIME DURING THE TREATMENT. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED REDNESS ON BOTH LOWER EYELIDS. THE FOLLOWING DAY THE PATIENT OBSERVED BLISTERS IN THE SAME AREA. THE PATIENT WAS PRESCRIBED AN UNKNOWN OINTMENT. THE PATIENT ALSO UNDERWENT 600 REPS OF THERMAGE FOR THE FACIAL AREA ON THE SAME DAY WITH A SEPARATE TREATMENT TIP, WHICH REPORTEDLY DID NOT OVERLAP WITH THE EYE TIP TREATMENT AREA. THE PATIENT¿S CURRENT STATUS, EIGHT DAYS POST TREATMENT, IS THE INJURY AREAS HAVE SCABBED AND THE SCABS HAVE STARTED TO PEEL OFF. IT¿S UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. A

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

    MAUDE report 18867851 ↗
  • InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED A CORNEAL INJURY 1 DAY POST THERMAGE FLX TREATMENT. AN EYE SHIELD WAS USED FOR THIS TREATMENT, IN ADDITION TO HI TEARS 1.4% (POLYVINYL ALCOHOL). THE PATIENT WAS ADMINISTERED SUPERFICIAL ANESTHETIC. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDED AN OPHTHALMOLOGIST TREATMENT. THE PATIENT'S CURRENT STATUS IS REPORTED AS UNRECOVERED EYE DISCOMFORT. OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED INCLUDE FACETIP 900. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS NOT EVER HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. THIS INCIDENT OCCURRED AT ABOUT 450 REPS. THE HIGHEST ENERGY LEVEL USED WAS 1.5 - 2.0. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY DURING TREATMENT. SOLTA MEDICAL CRYOGEN AND 30 ML OF COUPLING FLUID WERE USED DURING THIS TREATMENT. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE WITH NOTHING REMARKABLE. THE TREATMENT TIP SURFACE WAS NOT INSPECTED DURING THE TREATMENT. THIS SAME INDIVIDUAL TIP HAS NOT BEEN USED TO TREAT OTHER PATIENTS. THE REPORTING DOCTOR STAT

    Patient problems: Eye Injury; Eye Pain

    MAUDE report 18139277 ↗

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