Sofwave FG00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290018152003), received between Feb 28, 2022 and Mar 31, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 21, 2025, SOFWAVE RECEIVED A REPORT FROM FDA DESCRIBING AN EVENT ALLEGING LAXITY, THINNING, SAGGING AND DESCENT, ASYMMETRICAL VOLUME LOSS, FAT AND TISSUE ATROPHY, LOSS OF ELASTICITY, INFLAMMATION AND SIGNIFICANT PSYCHOLOGICAL AND EMOTIONAL INJURY, (MW5176208-1) BY THE PATIENT. THE INFORMATION WAS LIMITED AND SEVERAL FIELDS WERE REDACTED. PATIENT CONTACT INFORMATION WAS NOT AVAILABLE AND THEREFORE FURTHER FOLLOW-UP WITH THE PATIENT AND INVESTIGATION WAS NOT POSSIBLE. THE MANUFACTURER WAS UNABLE TO DETERMINE WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INJURIES DUE TO THE LACK OF CLINICAL, PROCEDURAL, AND PATIENT-SPECIFIC INFORMATION. IN ACCORDANCE WITH 21 CFR PART 803, A REPORT WAS SUBMITTED TO THE FDA BASED ON THE PATIENT'S ALLEGATION OF SERIOUS INJURY (COMPLAINT #(B)(4) FROM OCT 30, 2025). ALTHOUGH THE AVAILABLE INFORMATION WAS LIMITED, THE SUBMISSION WAS MADE OUT OF AN ABUNDANCE OF CAUTION AND IN COMPLIANCE WITH THE REQUIREMENTS OF 21 CFR PART 803. ON JANUARY 15, 2026, SOFWAVE BECAME AWARE ON A COMPLAINT FROM A PATIENT THAT REPORTED ON SIMILAR SYMPTOMS AND PROVIDED THE CLINIC NAME AND THE TREATMENT DATE. THE SUBJECT DEMOGRAPHIC, THE TREATMENT DATE ((B)(6) 2

  Patient problems: Insufficient Information

  MAUDE report 24747097 ↗
• InjuryDec 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON NOVEMBER 10, 2025 PREFERRED DEPOT BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5177743) ON OCTOBER 16, 2025. FDA FORWARDED THE EVENT TO PREFERRED DEPOT AND PREFERRED DEPOT FORWARDED TO THE MANUFACTURER ON NOVEMEBER 10TH, 2025 FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "I HAD 2 SOFTWAVE SKIN TIGHTENING TREATMENTS ON MY FACE BY DR. (B)(6). I WAS TOLD THERE ARE NO SERIOUS SIDE EFFECTS AND THIS IS A MINIMALLY INVASIVE TREATMENT THAT IS SUPPOSED TO HELP TIGHTEN MY SKIN AND IMPROVE THE QUALITY. INSTEAD, IT LEFT ME DEFORMED. MY EYES SUNKEN AND I LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA." PER THE MANUFACTURER, ADDITIONAL TREATMENT INFORMATION WAS NOT PROVIDED BY FDA AS SEVERAL FIELDS WERE REDACTED. PATIENT CONTACT INFORMATION WAS NOT AVAILABLE AND THEREFORE FURTHER FOLLOW-UP BY THE MANUFACTURER WITH THE PATIENT AND INVESTIGATION WAS NOT POSSIBLE. THE SUBJECT REPORTED THAT THE THERAPY LEFT HER "DEFORMED, . . SUNKEN EYES AND . . .LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA." PER THE MANUFACTURER, IT CANNOT CONFIRM WHETHER THE REPORTED CONDITION IS TEMPORARY OR PERMANENT OR RELATED TO THE DEVICE AS AVAILABLE COMPLAINT INFORMATION IS LIMITED AND DOES NOT

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 23771284 ↗
• InjuryDec 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON NOVEMBER 10, 2025, SOFWAVE BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5177743) ON OCTOBER 16, 2025. FDA FORWARDED THE EVENT TO SOFWAVE FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "I HAD 2 SOFTWAVE SKIN TIGHTENING TREATMENTS ON MY FACE BY DR. (B)(6). I WAS TOLD THERE ARE NO SERIOUS SIDE EFFECTS AND THIS IS A MINIMALLY INVASIVE TREATMENT THAT IS SUPPOSED TO HELP TIGHTEN MY SKIN AND IMPROVE THE QUALITY. INSTEAD, IT LEFT ME DEFORMED. MY EYES SUNKEN AND I LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA." ADDITIONAL TREATMENT INFORMATION WAS NOT PROVIDED BY FDA AS SEVERAL FIELDS WERE REDACTED. PATIENT CONTACT INFORMATION WAS NOT AVAILABLE AND THEREFORE FURTHER FOLLOW-UP WITH THE PATIENT AND INVESTIGATION WAS NOT POSSIBLE. THE SUBJECT REPORTED THAT THE THERAPY LEFT HER "DEFORMED. SUNKEN EYES AND LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA." THE MANUFACTURER CANNOT CONFIRM WHETHER THE REPORTED CONDITION IS TEMPORARY OR PERMANENT OR RELATED TO THE DEVICE. AVAILABLE COMPLAINT INFORMATION IS LIMITED AND DOES NOT ALLOW DETERMINATION OF CAUSALITY OR CONTRIBUTION BY THE DEVICE. NO DEVICE MALFUNCTION WAS REPORTED.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 23770420 ↗
• InjuryNov 28, 2025Break; Fracture; Break; Fracture

  ON NOVEMBER 2, 2025 PREFERRED DEPOT BECAME AWARE OF REPORTABLE EVENT THAT WAS REPORTED TO THE MANUFACTURER BY A PATIENT (MW5176922) ON SEPTEMBER 30, 2025. FDA FORWARDED THE EVENT TO MANUFACTURER FOR HANDLING (WHO SUBSEQUENTLY FORWARDED IT TO PREFERRED DEPOT). PATIENT REPORTED THE FOLLOWING: " ON (B)(6), I UNDERWENT A SOFWAVE PROCEDURE OF THE NECK AND FACE. THE PROBE HAS LEFT A STAMP ON MY FACE IN THE SHAPE OF AN H THAT IS NOT RESOLVING. THE PROVIDER WAS VERY UPSET AND SAID ALL SETTINGS WERE CORRECT. SOFWAVE TOLD THE PROVIDER THE PROBE WAS FAULTY AND PROVIDED HER A NEW ONE. SOFWAVE IS MARKETED AS A SAFE "ORGANIC" TREATMENT. I QUITE POSSIBLY HAVE BECOME PERMANENTLY DISFIGURED FROM SOFWAVE." ACCORDING TO THE MANUFACTURER, THIS INFORMATION WAS ASSOCIATED WITH A PREVIOUSLY RECEIVED COMPLAINT WITH THE SAME ALLEGATION OF HYPOPIGMENTATION AREA IN SHAPE OF TRANSDUCERS ON (B)(6) 2025. THE COMPLAINT INDICATED ON HYPOPIGMENTATION ON THE RIGHT MID CHEEK AFTER THE TREATMENT. THE MANUFACTURER INITIATED INVESTIGATION AND CLASSIFIED THIS EVENT AS NOT REPORTABLE. A MONTH AFTER, ON OCTOBER 20, 2025 THE CLINIC UPDATED THAT THE INJURY WAS IMPROVED AND THE INJURY IS MUCH LESS VISIBLE THAN ON TREATMENT D

  Patient problems: Hypopigmentation

  MAUDE report 23674107 ↗
• MalfunctionNov 28, 2025Break; Fracture; Break; Fracture

  ON OCTOBER 30, 2025, SOFWAVE BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5176922) ON SEPTEMBER 30, 2025. FDA FORWARDED THE EVENT TO SOFWAVE FOR HANDLING. PATIENT REPORTED THE FOLLOWING: " ON (B)(6), I UNDERWENT A SOFWAVE PROCEDURE OF THE NECK AND FACE. THE PROBE HAS LEFT A STAMP ON MY FACE IN THE SHAPE OF AN H THAT IS NOT RESOLVING. THE PROVIDER WAS VERY UPSET AND SAID ALL SETTINGS WERE CORRECT. SOFWAVE TOLD THE PROVIDER THE PROBE WAS FAULTY AND PROVIDED HER A NEW ONE. SOFWAVE IS MARKETED AS A SAFE "ORGANIC" TREATMENT. I QUITE POSSIBLY HAVE BECOME PERMANENTLY DISFIGURED FROM SOFWAVE." THIS INFORMATION WAS ASSOCIATED WITH A PREVIOUSLY RECEIVED COMPLAINT WITH THE SAME ALLEGATION OF HYPOPIGMENTATION AREA IN SHAPE OF TRANSDUCERS ON (B)(6) 2025. THE COMPLAINT INDICATED ON HYPOPIGMENTATION ON THE RIGHT MID CHEEK AFTER THE TREATMENT. SOFWAVE INITIATED INVESTIGATION AND CLASSIFIED THIS EVENT AS NOT REPORTABLE. A MONTH AFTER, ON (B)(6) 2025, THE CLINIC UPDATED THAT THE INJURY WAS IMPROVED AND THE INJURY IS MUCH LESS VISIBLE THAN ON TREATMENT DAY. PATIENT FINISHED A TWO-WEEK COURSE OF TOPICAL DESONIDE 0.05% CREAM.

  Patient problems: Hypopigmentation

  MAUDE report 23673635 ↗
• InjuryNov 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCTOBER 21, 2025 PREFERRED DEPOT BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5176208-1) ON SEPTEMBER 13, 2025. FDA FORWARDED THE EVENT TO PREFERRED DEPOT FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "I WAS SOLD 2 SOFWAVE PROCEDURES BY MY DERMATOLOGIST OFFICE AS A REJUVENATING TREATMENT. IT WAS DONE ON MY ENTIRE FACE, FOREHEAD, SUBMENTAL AND UPPER NECK REGIONS. THIS PROCEDURE CAUSED SIGNIFICANT AND DIFFUSE VOLUME LOSS, FAT AND TISSUE ATROPHY, LAXITY, THINNING, SAGGING AND DESCENT. I HAD VERY MINIMAL FACE AND NECK LAXITY PRIOR TO SOFWAVE, AND NOW HAVE SIGNIFICANTLY MODERATE LAXITY. IT CAUSED DEEP LINES AND INDENTATIONS, ESPECIALLY ABOVE THE EYEBROWS TO TEMPLES, LATERAL CHEEKS TO JAW, AND PERIORAL AREAS. I NOW HAVE DEEP NASOLABIAL LINES AND INDENTATIONS IN THE MARIONETTE REGION. I HAVE INCREASED LINES AROUND MY LIPS. THE SUPPORTING LAYER UNDERNEATH MY SKIN DECREASED GREATLY. THERE IS A LOSS OF SUBDERMAL/SUBCUTANEOUS STRUCTURE AND SUPPORT. MY SKIN NOW FOLDS AND COLLAPSES IN AREAS IT DID NOT PREVIOUSLY, ESPECIALLY IN THE PERIORAL REGIONS. THE TENDONS AND BONY STRUCTURES ARE VISIBLE AND MORE PROMINENT ON MY FOREHEAD. MY ENTIRE FACE; FROM THE FOREHEAD, B

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 23610487 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCTOBER 21, 2025 SOFTWARE BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5176208-1) ON SEPTEMBER 13, 2025. FDA FORWARDED THE EVENT TO SOFTWARE FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "I WAS SOLD 2 SOFTWARE PROCEDURES BY MY DERMATOLOGIST OFFICE AS A REJUVENATING TREATMENT. IT WAS DONE ON MY ENTIRE FACE, FOREHEAD, SUBMENTAL AND UPPER NECK REGIONS. THIS PROCEDURE CAUSED SIGNIFICANT AND DIFFUSE VOLUME LOSS, FAT AND TISSUE ATROPHY, LAXITY, THINNING, SAGGING AND DESCENT.  I HAD VERY MINIMAL FACE AND NECK LAXITY PRIOR TO SOFTWARE, AND NOW HAVE SIGNIFICANTLY MODERATE LAXITY.  IT CAUSED DEEP LINES AND INDENTATIONS, ESPECIALLY ABOVE THE EYEBROWS TO TEMPLES, LATERAL CHEEKS TO JAW, AND PERIORAL AREAS.  I NOW HAVE DEEP NASOLABIAL LINES AND INDENTATIONS IN THE MARIONETTE REGION.  I HAVE INCREASED LINES AROUND MY LIPS.  THE SUPPORTING LAYER UNDERNEATH MY SKIN DECREASED GREATLY.  THERE IS A LOSS OF SUBDERMAL/SUBCUTANEOUS STRUCTURE AND SUPPORT.  MY SKIN NOW FOLDS AND COLLAPSES IN AREAS IT DID NOT PREVIOUSLY, ESPECIALLY IN THE PERIORAL REGIONS.  THE TENDONS AND BONY STRUCTURES ARE VISIBLE AND MORE PROMINENT ON MY FOREHEAD.  MY ENTIRE FACE; FROM THE FOREHEAD, BROW

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 23427329 ↗
• InjuryAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AUGUST 11, 2025 SOFWAVE BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5173219) ON (B)(6) 2025. FDA FORWARDED THE EVENT TO SOFWAVE FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "HAD A SOFWAVE TREATMENTS WHICH USES ULTRASOUND ON MY FACE AND NECK. I WAS TOLD THE TREATMENT WAS SAFE FDA CLEARED WITH NO ADVERSE SIDE EFFECTS. THIS TREATMENT CAUSED NERVE DAMAGE AND EXTREME FAT LOSS IN MY FACE. SOFWAVE IS NOT SAFE AND SHOULD COME WITH A WARNING FOR THE FAT LOSS AND NERVE DAMAGE. SOFWAVE CLAIMS IT ONLY GOES 1.5 MM INTO SKIN AND IT CAN'T REACH THE FAT OR NERVES WHICH IS UNTRUE.". ADDITIONAL TREATMENT INFORMATION WAS NOT PROVIDED BY FDA AS SEVERAL FIELDS WERE REDACTED. THIS INFORMATION WAS ASSOCIATED WITH A PREVIOUSLY RECEIVED COMPLAINT WITH THE SAME ALLEGATION OF FAT LOSS AND NERVE DAMAGE:" I HAD SOFWAVE DONE TO MY UPPER FACE, LOWER FACE AND NECK. I HAVE SUBSTANTIAL FAT LOSS ALL OVER MY FACE AND I HAVE BEEN DIAGNOSED WITH SENSORY NERVE DAMAGE AND I'M IN GABAPENTIN TO HELP WITH THE BURNING PAIN. I THINK THE PROVIDER WENT BEYOND TREATMENT PROTOCOL. THE FAT ATROPHY IS SO EXTREME AT THIS POINT, I AM CONSULTING WITH PLASTIC SURGEON FOR FACIAL FAT GRAFTING".

  Patient problems: Burning Sensation; Insufficient Information; Nerve Damage

  MAUDE report 22923310 ↗
• InjuryMar 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2024, A FEMALE UNDERWENT SOFWAVE TREATMENT LASTING 45 MINUTES. PRE-TREATMENT SEDATION WAS APPLIED INCLUDED 18% LIDOCAINE AND 5% PRILOCAINE. TREATMENT AREA INCLUDED THE FACE (FOREHEAD, CHEEKS, PERI ORBITAL AND PERIORAL ) AND NECK. TREATMENT PARAMETERS INCLUDED A FLUENCE OF 3.8J ON THE LOWER FACE AND 3.4J ON FOREHEAD AND PERIORBITAL POST-COOLING DURATION WAS 2 SECONDS. OVERALL 258 PULSES WERE APPLIED (IN TWO PASSES). THE SUBJECT HAD SILICONE IMPLANTS (FOR MORE THAN 20 YEARS) IN HER LIPS. BASELINE PHOTOS OF THE PATIENT PRIOR TO TREATMENT DEMONSTRATE UNEVEN SWELLING OF THE UPPER LIP (MOST PRONOUNCED ON HER RIGHT SIDE OF HER LIP). SINCE HER SILICONE IMPLANT IS OLD, IT IS UNCLEAR WHETHER THE IMPLANT WAS IN THE RIGHT AREA WHERE IT WAS INJECTED. DURING TREATMENT OF THE PERI ORAL AREA PULSES WERE APPLIED NEAR AND ABOVE THE UPPER LIP (AT THE PERI ORAL AREA INCLUDING THE AREA BETWEEN THE UPPER LIP AND THE NOSE). ONE DAY POST-TREATMENT, THE SUBJECT REPORTED ON EDEMA IN HER UPPER LIP AREA (EXPECTED TISSUE RESPONSE FOLLOWING THE TREATMENT). CLINICAL INVESTIGATION WAS OPENED AND SOFWAVE WAS IN CONSTANT CONTACT WITH THE SITE TO FOLLOW ON THE SUBJECT CONDITION. PATIENT PHOTOS FROM DAY 1,

  Patient problems: Unspecified Infection

  MAUDE report 18869669 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (SKIN TYPE III-IV) UNDERWENT SOFWAVE TREATMENT ON (B)(6) 2022 ON FACE, NECK AND SUBMENTAL. PRONOX/TOPICAL BLT WAS USED AS PRE-TREATMENT SEDATION. AS WELL, SUBJECT ALSO TOOK SOME TYPE OF MEDICAL MARIJUANA AT HOME. PATIENT HAD BOTOX 2 WEEKS PRIOR TO THE TREATMENT (ON THE FOREHEAD, GLABELLA AND CROW'S FEET). TREATMENT PARAMETERS WERE 4.8-5.0J, 172 PULSES WERE APPLIED WITH 1 SECOND POST-COOLING IN CONTINUOUS MODE (1 SECOND INTERVAL). TREATMENT INCLUDED SINGLE PASS ON FOREHEAD, 3 PASSES ON CHEEKS AND 2 PASSES ON NECK. WELTS WITH THE APPLICATOR FOOTPRINT WERE OBSERVED ON THE PATIENT'S CHIN AREA IMMEDIATELY AFTER TREATMENT IN THE CLINIC. ONE DAY AFTER ((B)(6) 2022), THE PATIENT CALLED THE CLINIC TO NOTIFY OF THE APPLICATOR MARKS. TWO DAYS AFTER ((B)(6) 2022) SUBJECT WAS SEEN BY THE CLINIC DOCTOR AND HE REPORTED THAT BURNS WERE DEVELOPED WITH THE APPLICATOR FOOTPRINT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15014418 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT SOFWAVE TREATMENT AND DEVELOPED TINY BURNS IN THE CORNER OF HER NOSE, LIP AND CHIN. NO ERROR MESSAGES WERE REPORTED BY THE PROVIDER DURING THE TREATMENT. THERE WERE NO SPECIAL EVENTS OR ERROR MESSAGES DISPLAYED TO THE USER. THE APPLIED ENERGY FOR ALL PULSES DELIVERED DURING THE TREATMENT WAS WITHIN THE DEVICE SPECIFICATIONS. PRIOR TO TREATMENT, TOPICAL ANESTHETIC CREAM COMPOSED OF 23% LIDOCAINE AND 7% TETRACAINE WAS APPLIED FOR 45 MINUTES. ON (B)(6) 2022 THE PATIENT CONDITION WAS IMPROVED. ON (B)(6) 2022: THE PATIENT CONDITION CONTINUED TO IMPROVE SIGNIFICANTLY, AND FILLER WAS INJECTED TO THE CHIN INTO THE AFFECTED AREA TO ACCELERATE RECOVERY (3 WEEKS FOLLOWING SOFWAVE TREATMENT). ONE DAY FOLLOWING, THE EVENT COMPLETELY RESOLVED ((B)(6) 2022). WE BELIEVE IT IS UNCLEAR WHETHER THIS COSMETIC PROCEDURE WOULD BE CONSIDERED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR PERMANENT DAMAGE, BUT WE ARE, NONETHELESS, REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13620948 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT DEVELOPED 2 BURNS DURING SOFWAVE TREATMENT. THE SITE REPORTED THAT PRIOR TO THE EVENT OCCURRENCE AN ERROR MESSAGE #112 APPEARED ON THE SCREEN SEVERAL TIMES. ERROR MESSAGE #112 IS TO NOTIFY THE OPERATOR "PLEASE VERIFY GOOD CONTACT WITH SKIN. IF THE PROBLEM PERSISTS, PLEASE CONTACT SOFWAVE SUPPORT". ONE WEEK FOLLOWING THE EVENT BOTH BURNS WERE IMPROVED. THE PATIENT USED ALASTIN NECTRE (COLLAGEN AND ELASTIN CREAM) AND RECEIVED A FEW COMBINATION TREATMENTS OF PRP, MICRO-NEEDLING AND DYSPORT. WE BELIEVE IT IS UNCLEAR WHETHER THESE COSMETIC PROCEDURES WOULD BE CONSIDERED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR PERMANENT DAMAGE, BUT WE ARE NONETHELESS, REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. ABOUT TWO WEEKS AFTER SIGNIFICANT IMPROVEMENT WAS OBSERVED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13620659 ↗