Ulthera System Control UnitRecalls & reported problems across all models

We found 11 models of Ulthera System Control Unit by Ulthera, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2016 and May 21, 2026 — classified as 30 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. 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 Ulthera System Control Unit problems

Ulthera System Control Unit models

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

• Ulthera System Control Unit UC-1 Rev. D

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  7 reports
• Ulthera System Control Unit UC-1 Rev R

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  6 reports
• Ulthera System Control Unit UC-1 Rev. K

  System, Imaging, Pulsed Echo, Ultrasonic
  5 reports
• Ulthera System Control Unit UC-1 Rev. J

  System, Imaging, Pulsed Echo, Ultrasonic
  4 reports
• Ulthera System Control Unit UC-1 Rev. H

  System, Imaging, Pulsed Echo, Ultrasonic
  3 reports
• Ulthera System Control Unit UC-1 Rev. F

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  2 reports
• Ulthera System Control Unit UC-1 Rev. I

  System, Imaging, Pulsed Echo, Ultrasonic
  2 reports
• Ulthera System Control Unit UC-1 Rev. L

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  2 reports
• Ulthera System Control Unit UC-1 Rev. B

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  1 report
• Ulthera System Control Unit UC-1 Rev. C

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  1 report
• Ulthera System Control Unit UC-1 Rev. E

  Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
  1 report

Recent Ulthera System Control Unit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Use of Device Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS TREATED WITH ULTHERAPY ON (B)(6) 2026 IN THE AFTERNOON, FOR CHIN AND JAW LIFT, TARGETING SMAS AND FASCIA. A TOTAL OF 310 LINES WERE APPLIED USING DS 4-4.5MM TRANSDUCERS. THE PATIENT WAS CONCOMITANTLY TREATED WITH SYLFIRM X FOR A MORE SUPERFICIAL TREATMENT TO THE FACE, NECK, FOREHEAD, EYES, LIPS, AND NOSE. AS REPORTED, ABOUT 1025 PULSES WERE APPLIED WITH SYLFIRM X. TREATMENT AREAS WERE MARKED TO ENSURE THE AREAS WERE IN SAFETY ZONES. THIS WAS THE PATIENT'S FIRST EXPERIENCE WITH AESTHETIC TREATMENTS. PATIENT SKINCARE PRODUCTS WERE REPORTED AS NEO FIRM, LUMIERE FIRM, EPIONCE RENEWAL LIGHT MOISTURIZER, AND A GENTLE CLEANSER. CONTROL UNIT, HANDPIECE, AND TRANSDUCER SERIAL NUMBERS USED DURING TREATMENT WERE REPORTED AS (B)(6), RESPECTIVELY. ON (B)(6) 2026, THREE HOURS AFTER TREATMENT WITH ULTHERAPY, THE PATIENT EXPERIENCED SUSPECTED INFLAMMATION ON THE FRONTAL NERVE BRANCH, MUSCLE WEAKNESS ABOVE THE RIGHT EYEBROW/ACUTE DROOPING, ERYTHEMA, AND MILD EDEMA. AFTER ALL TREATMENTS WERE COMPLETED, TOPICAL EXOSOMES WERE APPLIED TO PROMOTE HEALING. THE PATIENT CALLED IN THE AFTER

  Patient problems: Erythema; Muscle Weakness/Atrophy; Nerve Damage; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 25244373 ↗
• InjuryOct 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SPONTANEOUS REPORT RECEIVED FROM A BRAZILIAN AFFILIATE ON (B)(6) 2025 CONCERNS A FEMALE PATIENT OF UNKNOWN AGE. ON (B)(6) 2025, THE PATIENT WAS TREATED WITH THE ULTHERA SYSTEM USING A DS10-1.5 TRANSDUCER FOLLOWING THE EYEBROW LIFT GUIDELINE. DURING TREATMENT, THE PROVIDER ACCIDENTALLY DELIVERED A LINE TO THE RIGHT EYE REGION OF THE PATIENT, CAUSING BLEEDING AT THE TIME AND BLURRED VISION. USE OF LIDOCAINE/ANESTHETIC DURING THE TREATMENT WAS NOT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE EVENT WERE MADE (B)(6) 2025. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23315814 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT RECEIVED FROM A UNITED STATES PATIENT¿S SPOUSE CONCERNS A 52-YEAR-OLD ASIAN, FILIPINO FEMALE PATIENT. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH ULTHERA SYSTEM FOR AN UNKNOWN INDICATION. THE PATIENT WAS NUMBED WITH TOPICAL LIDOCAINE/TETRACAINE 27%/7%. ON AN UNSPECIFIED DATE, POST-TREATMENT WITH ULTHERA SYSTEM, THE PATIENT EXPERIENCED BURN MARKS ON HER FACE IN TWO PLACES (PER REPORT FROM PATIENT'S SPOUSE) AND A BLISTER AND SCAR (REPORTED BY THE TREATMENT SITE). ON (B)(6) 2025, THE PATIENT'S SPOUSE EMAILED STATING: MY WIFE HAD TREATMENTS AT ONE OF YOUR PROVIDERS. THE UL THERAPY BURNED HER FACE IN TWO PLACES. THE PROVIDER HAS TRIED TO MITIGATE THE BURN MARKS, BUT THEY ARE BURNED INTO HER FACE. YOU CAN FEEL AS WELL AS SEE THEM. WE HAVE GOTTEN A SECOND OPINION FROM ANOTHER OF YOUR PROVIDERS. THEY ALL AGREE THAT HER FACE HAS SUFFERED IRREPARABLE DAMAGE AS A RESULT OF YOUR MACHINE NOT FUNCTIONING PROPERLY. THE PATIENT'S SPOUSE EMAILED FOLLOW-UP INFORMATION ON (B)(6) 2025 STATING: THE PROVIDER IS DR. (B)(6). SHE HAS BEEN VERY HELPFUL AND GIVEN FREE TREATMENT TO MY WIFE TO TRY AND MITIGATE THE SCAR. HOWEVER, IT HAS NOT WORKED. FOLLOW-UP INFORMATION WAS RECEIVED FRO

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

  MAUDE report 22310240 ↗
• InjuryDec 3, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SPONTANEOUS REPORT RECEIVED FROM (B)(6) AFFILIATE ON (B)(6)2024 CONCERNING A 41-YEAR-OLD FEMALE PATIENT. ACCORDING TO THE REPORT, THE PATIENT HAD ULTHERAPY PERFORMED ON THE LOWER FACE USING STANDARD PROTOCOL WITH ULTHERA DS 4-4.5, DS 7-3.0, AND DS 10-1.5 TRANSDUCERS (TOTAL LINES DELIVERED: (B)(4)). TREATMENT WAS PERFORMED IN (B)(6) 2023 WITH A VERY EXPERIENCED THERAPIST WHO HAS BEEN PERFORMING ULTHERAPY FOR MANY YEARS. AFTER THE SESSION, THE PATIENT DEVELOPED A UNILATERAL DENT IN THE RIGHT POSTERIOR JAWLINE AREA. FOLLOW-UP INFORMATION WAS RECEIVED ON 31-OCT-2024. ACCORDING TO THE REPORT, THE PATIENT IS A 41-YEAR-OLD, CAUCASIAN, FEMALE TREATED WITH ULTHERA SYSTEM ON (B)(6)2023 ON THE LOWER FACE USING DS 4-4.5, DS 7-3.0, AND DS 10-1.5 TRANSDUCERS. A TOTAL OF (B)(4) LINES WERE DELIVERED. THE PATIENT WAS GIVEN 800MG IBUPROFEN AND 1000MG PARACETAMOL ORALLY AND TOPICAL LMX4 WAS APPLIED BUT REMOVED PRIOR TO TREATMENT. THE PATIENT'S CONDITION IMMEDIATELY AFTER TREATMENT WAS NOTED AS NOTHING UNUSUAL. CURRENTLY, THE PATIENT'S CONDITION IS ATROPHY IN THE RIGHT POSTERIOR JAWLINE AND NO SYMPTOMS HAVE RESOLVED. THE PATIENT HAS A HISTORY OF NEEDLING, BUT NO HISTORY OF ULTHERA TREATMENTS. THE

  Patient problems: Insufficient Information

  MAUDE report 20836835 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11-OCT-2024, ULTHERA RECEIVED INFORMATION FROM A BRAZILIAN AFFILIATE VIA EMAIL REGARDING A POTENTIAL ULTHERA ADVERSE EVENT. ACCORDING TO THE REPORT, ULTHERAPY WAS PERFORMED ON A MALE PATIENT, DEMOGRAPHICS UNKNOWN, TO THE MIDDLE THIRD OF THE FACE ON (B)(6) 2024. THE FOLLOWING DAY, (B)(6) 2024, THE PATIENT ALLEGEDLY EXPERIENCED A ¿GRADE 3¿ BURN ON THE LOWER THIRD OF THE LEFT SIDE OF THE FACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT¿S TREATMENT AND PATIENT SYMPTOM RESOLUTION WERE MADE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20592305 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS RECEIVED FROM A CANADIAN CLINIC PHYSICIAN CONCERNING A FEMALE PATIENT. THE PRACTICE INITIALLY REPORTED ON (B)(6) 2023 A PATIENT RECEIVED AN ULTHERAPY FACE AND NECK TREATMENT ON (B)(6) 2023 AND EXPERIENCED WELTING IMMEDIATELY AFTER TREATMENT. TWO WEEKS LATER, THE MARKS WERE STILL THERE AND CHANGED SLIGHTLY IN COLOR (MORE RED). ON (B)(6) 2024 THE PHYSICIAN PROVIDED AN UPDATE STATING THE PATIENT CAME IN FOR AN APPOINTMENT FOR BOTOX AND REPORTED THE PATIENT HAS TWO RED MARKS UNDER THE JAWLINE LATERALLY ON BOTH SIDES OF HER NECK SINCE ULTHERAPY TREATMENT. THE PATIENT STATED THERE WAS INITIALLY A SWOLLEN BAND ON EACH SIDE FROM ANGLE OF THE JAW TO APPROXIMATELY THE START OF THE MARIONETTE LINE IN THIS AREA. THE SWELLING RESOLVED, BUT THE REDNESS REMAINS ESPECIALLY ON THE LEFT SIDE. THE RIGHT SIDE IS LESS RED AND LOOKS A LITTLE INDENTED. THE LEFT SIDE IS STILL RED, AND SHE FEELS IS STILL A LITTLE SWOLLEN BUT DOES NOT APPEAR INDENTED. THE PHYSICIAN REPORTED IT LOOKS AS IF SHE MAY HAVE A BURN. ON (B)(6) 2024 THE TREATING CLINIC PROVIDED A COMPLETED QUESTIONNAIRE WITH ADDITIONAL INFORMATION RELATED TO TREATMENT ON THIS PATIENT. PER THE QUESTIONNAIRE: THE FULL FACE AND NECK WAS

  Patient problems: Burn(s); Deformity/ Disfigurement; Scar Tissue

  MAUDE report 18727141 ↗
• InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 13-DEC-2023, A MERZ PRODUCT DEVELOPMENT SPECIALIST (PDS) REPORTED VIA PHONE THAT ON (B)(6) 2023 A PATIENT EXPERIENCED AN ADVERSE EVENT. THE PDS STATED: "[PATIENT] RECEIVED SWELLING/BURNS ON THE NECK, FACE, AND MOUTH, AS WELL AS NERVE DAMAGE, NUMBNESS, AND SHOOTING PAINS TO THE TOP OF THE HEAD. PATIENT ALSO EXPERIENCING SKIN HYPERSENSITIVITY." TEXT MESSAGES FROM THE TREATING PHYSICIAN WERE ALSO RECEIVED ON 13-DEC-2023. THE PHYSICIAN STATED: "[PATIENT] HAS SWELLING AND BURNS ON THE FACE, NECK, AND INSIDE THE MOUTH [THAT] ARE EXTENSIVE. I WILL ARRANGE FOR FORMAL PHYSICAL EXAMINATION BY INDEPENDENT PRACTITIONER AS WELL AS NEUROLOGIST SINCE [PATIENT] HAS NUMBNESS IN PARTS OF HER FACE, PARESTHESIAS, DYSESTHESIAS, SHOOTING PAINS TOWARD THE TOP OF HER HEAD, AND HYPERSENSITIVE SKIN IN OTHER AREAS." ON 21-DEC-2023, MERZ PRODUCT SAFETY PROVIDED AN EMAIL UPDATE. PER THE EMAIL, THE TREATING PHYSICIAN REPORTED VIA PHONE (ON (B)(6) 2023) THAT: "[PATIENT] IS EXPERIENCING SIGNIFICANT NERVE SENSITIVITY. THIS HAS PERSISTED FROM THE NIGHT OF (B)(6) 2023 TO PRESENT WITH NO SIGNS OF IMPROVEMENT. [PATIENT] HAD A FULL FACE AND NECK TREATMENT AND OPTED FOR NO PAIN MANAGEMENT. PAIN DURING TREATMENT WAS D

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Deformity/ Disfigurement; Headache; Nerve Damage; Pain; Salivary Gland Problem; Scar Tissue; Skin Discoloration; Skin Infection; Swelling/ Edema; Urticaria

  MAUDE report 18498380 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A UNITED KINGDOM HEALTHCARE PROFESSIONAL REPORTED TO A MERZ AFFILIATE CONCERNS REGARDING A PATIENT TREATED WITH ULTHERAPY VIA EMAIL. ACCORDING TO THE REPORT, A PATIENT HAD ULTHERAPY ON THE LOWER FACE AND SUBMENTAL AREA ON (B)(6) 2022. THE PATIENT ALLEGEDLY EXPERIENCED CAT SCRATCH-LIKE SWELLING ON HER FACE FOLLOWING TREATMENT. FOUR MONTHS SINCE TREATMENT, THE CAT SCRATCH-LIKE MARKS SEEM TO BE PITTED SCARS, WHICH WORRIED THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED ON (B)(6) 2023. BASED ON THE INFORMATION PROVIDED, A 32-YEAR-OLD FEMALE PATIENT WAS TREATED WITH 500 LINES DELIVERED USING DS 4.5, DS 3.0, AND DS 1.5 TRANSDUCERS. ULTHERAPY GUIDELINES AND PROTOCOL FROM TRAINING WERE USED. NUMBING CREAM THAT CONTAINS LIDOCAINE WAS USED ON THE PATIENT PRIOR TO TREATMENT. ULTRASOUND GEL WAS USED DURING TREATMENT. IMMEDIATELY POST-PROCEDURE, THE PATIENT EXPERIENCED TENDERNESS AND 3X CAT SCRATCH WELTS WERE IDENTIFIED IN THE AREA. THE PATIENT WAS ADVISED TO MOISTURIZE. THE PATIENT HAD A FACE-TO-FACE REVIEW WITH THE PRACTICE'S MEDICAL TEAM ON (B)(6) 2023. THE CAT-SCRATCHED LOOK WELTS TURNED OUT TO BE IDENTIFIED SCARS. THE SCARS WERE IDENTIFIED IN THE SAME A

  Patient problems: Erythema; Pain; Scar Tissue; Urticaria

  MAUDE report 17054203 ↗
• MalfunctionDec 21, 2022No Display/Image; Sparking; No Display/Image; Sparking

  ON (B)(6) 2022, A CUSTOMER REPORTED VIA PHONE CALL AN ULTHERA CONTROL UNIT THAT WAS GIVING A BLANK SCREEN. UPON TURNING OFF THIS DEVICE AND POWERING BACK ON, SPARKS WERE OBSERVED EMITTING FROM THE CONNECTION WHERE THE POWER CORD CONNECTS TO THE BACK OF THE CONTROL UNIT. TROUBLESHOOTING WAS PERFORMED BY REQUESTING THE USER TO UNPLUG THE DEVICE AND ENSURE THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. UPON CONFIRMATION OF THE POWER CORD BEING FULLY SEATED, THE DEVICE WAS AGAIN PLUGGED INTO AN OUTLET. WHEN THE UNIT WAS PLUGGED IN, SPARKS WERE REPORTEDLY EMITTING FROM THE SAME LOCATION ON THE BACK OF THE CONTROL UNIT. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025842 ↗
• MalfunctionDec 21, 2022Failure to Power Up; Sparking; Failure to Power Up; Sparking

  WHILE TROUBLESHOOTING ISSUES WITH AN ULTHERA SYSTEM FOR AN UNRELATED EVENT ON (B)(6) 2022, A CUSTOMER ALLEGED THAT SPARKS EMITTED FROM THE BACK OF THEIR CONTROL UNIT. THE USER STATED THE SPARKS ORIGINATED FROM THE AREA OF THE CONNECTION OF THE POWER CORD TO THE BACK OF THE MACHINE, AND OCCURRED WHEN THE SYSTEM WAS TURNED ON. FOLLOWING THIS EVENT, THE SYSTEM WOULD NO LONGER TURN ON. THE USER STATED THE PLUG APPEARED INTACT WITH NO SIGN OF FRAYING, AND THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. THE USER WAS DIRECTED TO CEASE USE OF THIS SYSTEM IMMEDIATELY. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025772 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TREATMENT PROVIDER REPORTED TO MERZ/ULTHERA ON (B)(6) 2022 VIA PHONE CALL REGARDING A PATIENT THAT WAS TREATED WITH ULTHERAPY. ACCORDING TO THE REPORT, THE PATIENT CAME INTO THE PRACTICE "APPROXIMATELY 1 WEEK AGO" AND REPORTED RECEIVING WELTS ON HER NECK AND CHEEK FROM AN ULTHERAPY TREATMENT RECEIVED ON (B)(6) 2022. THE PROVIDER INDICATED THAT THEY DID NOT IDENTIFY ANYTHING ON THE PATIENT'S CHEEK; HOWEVER, THEY DID IDENTIFY HYPO-PIGMENTATED MARKINGS ON THE NECK. DURING FOLLOW UP FOR THIS INITIAL REPORT, THE TREATMENT PROVIDER INDICATED VIA PHONE CALL THAT THEY "BELIEVE THE SCAR WOULD NOT BE PERMANENT, BUT WOULD TAKE A LONG TIME TO HEAL." THE PRACTICE INDICATED THIS PATIENT HAD ULTHERAPY TREATMENTS THREE TIMES PRIOR TO THIS TREATMENT ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021. FOR THE (B)(6) 2022 TREATMENT, THE REPORTER STATED THE PATIENT WAS TREATED ON THE FACE AND NECK WITH 310 LINES USING A DS 10-1.5 (1.5 MM DEPTH). A REVIEW OF THE SUPPORT LOG FOUND THAT THIS PATIENT WAS ACTUALLY TREATED WITH 360 LINES, AND REVEALED RECOMMENDED GUIDELINES WERE FOLLOWED DURING TREATMENT. THE TREATMENT PROVIDER STATED THAT NO MALFUNCTIONS OCCURRED DURING TREATMENT, AND ALL EQUIPMENT PERFORMED A

  Patient problems: Skin Discoloration; Wheal(s)

  MAUDE report 15601474 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-AUG-2022, A MERZ RUSSIA AFFILIATE REPORTED VIA EMAIL OF A POTENTIAL ULTHERA ADVERSE EVENT. THE AFFILIATE STATED: "ON (B)(6) THE PATIENT I.O.V. (37 YEARS OLD) HAD TREATMENT WITH ULTHERA PROCEDURE (5 PLUS PROTOCOL). PHOTOS BEFORE AND AFTER PROCEDURE WAS NOT TAKEN. THE KETANOV WAS GIVEN BEFORE THE PROCEDURE. AFTER ULTHERA PROCEDURE THE PATIENT HAD DISPORT PROCEDURE (60 UNITS). A WEEK LATER THE PATIENT INFORMED THE PHYSICIAN ABOUT NUMBNESS ON THE FACE. DUE TO THE PATIENT'S LOCATION IN SPAIN FOR THAT TIME IT WAS NOT POSSIBLE FOR THE PHYSICIAN TO EXAMINE HER. THE PHYSICIAN EXPLAINED VIA THE PHONE CALL THAT SUCH HP (NUMBNESS) IS POSSIBLE AND ASKED TO BE IN TOUCH. ON AUGUST, 18, THE PATIENT INFORMED THE PHYSICIAN THAT SHE IS IN CLINIC CAUSE OF DIFFICULTY IN BREATHING, TONGUE EDEMA AND NASAL CONGESTION. ON MRI AND CT THERE WAS NOT FOUND ANY PATHOLOGY; REFLEXES ARE NORMAL. THE PHYSICIAN ASKED THE PATIENT THE MRI AND KT CONCLUSION AND ALSO SUGGESTED TO HAVE A CONSULTATION WITH NEUROLOGIST ONLINE. THE PATIENT HASN'T ANSWERED TO THE PHYSICIAN FOR THE PRESENT TIME." ADDITIONAL TREATMENT INFORMATION WAS RECEIVED FROM THE MERZ RUSSIA AFFILIATE ON (B)(6) 2022. ACCORDING TO THE PHYSICIAN, THIS

  Patient problems: Dyspnea; Neuropathy; Swelling/ Edema

  MAUDE report 15512248 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-JUN-2020, ULTHERA RECEIVED INFORMATION FROM A MERZ (B)(6) AFFILIATE REGARDING AN ADVERSE EVENT RELATED TO AN ULTHERAPY TREATMENT PERFORMED ON (B)(6) 2020. THE AFFILIATE REPORTED, "WE HAVE RECEIVED SOME COMPLAINTS OF PATIENT INJURIES." NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME. ON 27-OCT-2020, THE AFFILIATE REPORTED ADDITIONAL INFORMATION REGARDING THIS EVENT. ACCORDING TO THE REPORT, "THE PATIENT HAS RECEIVED AN ULTHERAPY FULL FACE AND NECK TREATMENT USING DS4-4.5 AND DS7-3.0 ON (B)(6) 2020. SHE HAD SWELLING AND ERYTHEMA ON HER NECK IMMEDIATELY AFTER THE TREATMENT, BLISTERS APPEARED ON THE NECK ON (B)(6) 2020. THE PATIENT VISITED A DERMATOLOGIST ON (B)(6) 2020, SHE WAS DIAGNOSED BURNT ON THE NECK SKIN DUE TO THE HEAT OF ULTHERA TREATMENT. SOME SECONDARY BACTERIAL INFECTION WAS PRESENTED IN THE AREA WITH YELLOW PUS DOTS. THE DERMATOLOGIST HAS PRESCRIBED BACTROBAN OINTMENT AND ORAL ANTIBIOTICS TO THE PATIENT. UPON FOLLOW UP SESSION WITH THE SAME DERMATOLOGIST ON (B)(6) 2020, THE PATIENT HAD GRADUAL IMPROVEMENT AND WITH THE BLISTERS SUBSIDED, BUT RED SCAR TISSUE APPEARED. THE PATIENT WERE PRESCRIBED SILICONE GEL AND 20% AZELAIC ACID CREAM FOR SCAR AND POST-INFLAMMATORY

  Patient problems: Erythema; Partial thickness (Second Degree) Burn; Pyogenic Infection; Swelling/ Edema

  MAUDE report 12925282 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-JUN-2020, ULTHERA RECEIVED INFORMATION REGARDING A REPORT OF UNKNOWN PATIENT INJURY RESULTING FROM ULTHERAPY FROM MERZ (B)(6) AFFILIATE VIA EMAIL. ON 16-OCT-2020, ULTHERA RECEIVED ADDITIONAL INFORMATION FROM A MERZ (B)(6) AFFILIATE REGARDING AN ADVERSE EVENT ASSOCIATED WITH AN ULTHERAPY TREATMENT. PER THE INFORMATION RECEIVED, THE AFFILIATE REPORTED "DOCTOR COMMENTED THAT THERE WAS MILD REDNESS OVER THE NECK OF THE PATIENT POST-TREATMENT, AND THUS PRESCRIBED HYDROCORTISONE 1% LA BD FOR FIVE DAYS. PATIENT COMPLAINED OF BLISTER AT JUNCTION OF SUBMENTAL AND NECK AT NIGHT ON (B)(6) 2020, AND THE BLISTER PERFORATED ON (B)(6) 2020. THE PATIENT HAS THEN VISITED A DERMATOLOGIST ON (B)(6) 2020 FOR WOUND MANAGEMENT. PER PATIENT REPORT, THE DERMATOLOGIST COMMENTED THAT AFTER THE SCAB FALL OFF, RED MARK MAY LEFT AT THE BEGINNING, AND TURN INTO BROWN MARK. IT MAY TAKE FEW MONTHS FOR RECOVER. ON THE NEXT FOLLOW-UP SESSION ON (B)(6) 2020, THE DERMATOLOGIST DIAGNOSED THAT THE PATIENT HAS POST-ULTHERAPY BULLA." ON 24-OCT-2020, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PRACTICE CONTAINING PATIENT AND TREATMENT DETAILS AS WELL AS STATING THE ULTHERA EQUIPMENT PERFORMED AS INTENDED AND NO MAL

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 12923904 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERZ/ULTHERA RECEIVED INFORMATION FROM A PRACTICE ON 05-JAN-2021 REGARDING AN ULTHERA ADVERSE EVENT. THE REPORTER ALLEGED, "WE HAVE A 67-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FULL FACE ULTHERAPY TREATMENT IN (B)(6) 2019 WITH OUR MASTER AESTHETICIAN, (REDACTED) (WHO IS NO LONGER WITH THE COMPANY). THE PATIENT FEELS LIKE SHE HAS EXPERIENCED FACIAL ATROPHY FOLLOWING HER TREATMENT. SHE HAS NEVER HAD COSMETIC FILLERS AND HAS GAINED ABOUT 15 POUNDS IN AN EFFORT TO REGAIN WEIGHT IN HER FACE." THE PRACTICE REPORTED ADDITIONAL INFORMATION ON 26-JAN-2021, STATING THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2020 AND HAS NO ADDITIONAL FOLLOW-UP APPOINTMENTS SCHEDULED. THE REPORTING PHYSICIAN CLAIMED THAT THE PATIENT HAS EXPERIENCED A PROGRESSIVE LOSS OF FACIAL VOLUME OVER THE PAST YEAR FOLLOWING MULTIPLE ULTHERAPY TREATMENTS. THE PATIENT'S HISTORY OF ULTHERAPY TREATMENTS INCLUDE: FULL FACE TREATMENT ON (B)(6) 2019, FULL NECK AND PERIORAL TREATMENT ON (B)(6) 2019, AND REPEAT PERIORAL TREATMENT ON (B)(6) 2019. THE REPORTER ALLEGED THE PATIENT HAS BEEN GAINING WEIGHT IN AN ATTEMPT TO INCREASE FACIAL VOLUME; HOWEVER, THIS HAS NOT HELPED. THE PATIENT HAS NO OTHER MEDICAL PROBLEMS THAT WOULD ATTRIBUTE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Bruise/Contusion; Deformity/ Disfigurement; Difficulty Chewing; Dry Eye(s); Headache; Hyperpigmentation; Nervous System Injury; Pain; Paresis; Skin Discoloration; Tissue Breakdown; Vitreous Floaters

  MAUDE report 12909002 ↗