EVOLYSSE FORM EVOF1F001Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 03760172161264), received between Aug 26, 2025 and Sep 30, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Off-Label Use” (26 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Off-Label Use; Patient-Device Incompatibility

  Patient problems: Anaphylactoid / Anaphylaxis; Dyspnea; Low Blood Pressure/ Hypotension; Pallor

  MAUDE report 50950438 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  An HCP reported injecting 0.2 cc of Evolysse Form into a patient's pyriform aperture using a 25-gauge cannula. When the tissue blanched, the HCP immediately withdrew the cannula, injected two vials of Hylenex, applied a warm compress, and massaged the area. The patient subsequently developed bruising and mottling. An MD confirmed a vascular occlusion in the left nasolabial fold, which resolved after ultrasound-guided Hylenex treatment.

  Patient problems: Bruise/Contusion; Obstruction/Occlusion; Pallor

  MAUDE report 50803126 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  An HCP reported injecting 0.2 cc of Evolysse Form into a patient's pyriform aperture using a 25-gauge cannula. When the tissue blanched, the HCP immediately withdrew the cannula, injected two vials of Hylenex, applied a warm compress, and massaged the area. The patient subsequently developed bruising and mottling. An MD confirmed a vascular occlusion in the left nasolabial fold, which resolved after ultrasound-guided Hylenex treatment.

  Patient problems: Bruise/Contusion; Obstruction/Occlusion; Pallor

  MAUDE report 50692220 ↗
• InjurySep 1, 2026Off-Label Use; Patient-Device Incompatibility

  An HCP reported injecting, 0.5 mL of Evolysse Form into the lips and 0.25 mL to each pyriform/nasolabial region via cannula on (b)(6) 2026. The patient had no immediate complications. On (b)(6) 2026 the patient had a routine dental cleaning after which on (b)(6) 2026, the patient experienced lip swelling and tenderness to the touch similar to that immediately following the initial injection of Evolysse. The patient presented to the HCP's office and Urgent Care on (b)(6) 2026 and was diagnosed with possible cellulitis/reactive lymph node and started on Augmentin and Zyrtec.The following day, (b)(6) 2026 the patient experienced worsening lip swelling and returned to urgent care. Patient was advised to apply a warm compress; no additional treatment was performed. On (b)(6) 2026 the patient presented to the ER and received intravenous corticosteroids, and a Medrol Dosepak. Patient was advised to discontinued Augmentin. The patient reported recurrent swelling from (b)(6) 2026 to the HCP who prescribed 100mg of Doxycycline BID for 10 days. The patient returned to the ER due to worsening swelling and was treated with additional intravenous steroids. A CT scan was performed and negative fo

  Patient problems: Angioedema; Hypersensitivity/Allergic reaction; Local Reaction; Pain; Subcutaneous Nodule; Swelling/ Edema; Ulcer

  MAUDE report 50547539 ↗
• InjuryAug 31, 2026Off-Label Use; Patient-Device Incompatibility

  Patient problems: Angioedema; Hypersensitivity/Allergic reaction; Local Reaction; Pain; Subcutaneous Nodule; Swelling/ Edema; Ulcer

  MAUDE report 50530884 ↗
• InjuryAug 17, 2026Off-Label Use

  On (b)(6) 2026, A patient was injected with 0.7 mL of Evolysse Form in the lips via the provided 30-gauge needle during an onsite training session at her place of employment. An additional 0.1 mL was injected into the cheek. The HCP noted the patient's lips looked "beautiful" but swelled more than previous lip procedures. Before the two-week follow-up, the patient reported palpable lumps in the lips. The provider advised allowing time for the filler to integrate and planned reassessment at two weeks. The patient subsequently reported that the lips felt heavy and using a straw was painful. The HCP examined the patient and could not palpate any lumps or bumps in the lips. However, the filler was dissolved at the patient's request using five vials of Hylenex. The provider reported palpating deep nodules that were not visible in the wet mucosa. Over the next four months, the provider dissolved the filler on multiple dates using a total of 21 vials of Hylenex. The patient and provider reported improvement; however, residual nodules remain. No adverse reaction was noted in the cheeks.

  Patient problems: Pain; Subcutaneous Nodule; Swelling/ Edema

  MAUDE report 50288692 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  An HCP injected Evolysse (type unspecified) into the chin, lips, and midface of a female patient on (B)(6) 2026 during a training event. A few days post injection on (B)(6) 2026, the patient experienced pain, lumps, and blurry vision. The patient was seen by another HCP who injected the patient with 8 vials of Hylenex in the cheek area to dissolve as much of the product as possible. As of 22-Jul-2026, the patient's vision improved.

  Patient problems: Blurred Vision; Neuralgia; Pain; Subcutaneous Nodule

  MAUDE report 50255051 ↗
• InjuryJul 29, 2026Off-Label Use

  A patient reported being injected with Evolysse Form in the lips during an onsite training session at her place of employment on (b)(6) 2026. After an unspecified period of time the patient experienced persistent, hard nodules throughout her lips. The patient reported undergoing multiple treatments to dissolve the product with 21 vials of Hylenex. As of (b)(6) 2026, the patient reported the product is still not fully dissolved.

  Patient problems: Pain; Subcutaneous Nodule; Swelling/ Edema

  MAUDE report 50075174 ↗
• InjuryJun 9, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  AN HCP REPORTED INJECTING 2CC'S OF EVOLYSSE FORM BILATERALLY INTO THE MIDFACE AND CHEEKS OF A FEMALE PATIENT ON (B)(6) 2026. ONE (1) DAY FOLLOWING THE INJECTION ON (B)(6) 2026, THE PATIENT RETURNED TO THE OFFICE EXPERIENCING PAIN AND SWELLING OF THE RIGHT CHEEK. THE HCP PRESCRIBED ORAL ANTIBIOTICS OF DOXYCYCLINE AND KEFLEX. ON (B)(6) 2026, THE HCP DRAINED THE RIGHT CHEEK AND COLLECTED A CULTURE WHICH CAME BACK POSITIVE FOR A STAPHYLOCOCCAL INFECTION. THE SAME DAY THE HCP ADMINISTERED AN INJECTION OF KENALOG. ON (B)(6) 2026 THE HCP ADMINISTERED A SECOND KENALOG INJECTION. A SMALL NODULE REMAINED WHICH WAS INJECTED WITH HYLENEX ON (B)(6) 2026. THEN THE PATIENT WAS RE-INJECTED WITH EVOLYSSE FORM ON (B)(6) 2026. PROCEDURE PREPARATION: THE HCP CLEANED THE INJECTION AREA WITH ALCOHOL, HIBICLENS, AND PURACYN.

  Patient problems: Bacterial Infection; Pain; Subcutaneous Nodule; Swelling/ Edema

  MAUDE report 25444417 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.5ML OF EVOLYSSE FORM WITH 5 INJECTIONS BILATERALLY WITH A RETROGRADE TECHNIQUE WITHIN THE SUBCUTANEOUS TISSUE OF THE NASOLABIAL FOLDS WITH A 27GAGE NEEDLE. NO SYMPTOMS WERE REPORTED IMMEDIATELY POST-PROCEDURE. HOWEVER, LATE ON (B)(6) 2026, THE PATIENT CONTACTED THE HCP AND REPORTED REDNESS TO THE AREA UP TOWARDS THE LOWER EYE AREA. THE PATIENT WAS SEEN IN OFFICE ON (B)(6) 2026 AND THE RIGHT NASOLABIAL FOLD WAS TREATED WITH 4 VIALS OF HYLENEX, WARM COMPRESSES, AND NITROGLYCERIN. THE PATIENT'S CAPILLARY REFILL RETURNED TO NORMAL SHORTLY THEREAFTER. HCP REPORTED CONTINUED IMPROVEMENT 12 HOURS POST HYLENEX TREATMENT. HCP REPORTED PROPER ASPIRATION TECHNIQUE WAS FOLLOWED.

  Patient problems: Erythema; Obstruction/Occlusion

  MAUDE report 24866815 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.5ML OF EVOLYSSE FORM WITH 5 INJECTIONS BILATERALLY WITH A RETROGRADE TECHNIQUE WITHIN THE SUBCUTANEOUS TISSUE OF THE NASOLABIAL FOLDS WITH A 27GAGE NEEDLE. NO SYMPTOMS WERE REPORTED IMMEDIATELY POST-PROCEDURE. HOWEVER, LATE ON (B)(6) 2026, THE PATIENT CONTACTED THE HCP AND REPORTED REDNESS TO THE AREA UP TOWARDS THE LOWER EYE AREA. THE PATIENT WAS SEEN IN OFFICE ON (B)(6) 2026 AND THE RIGHT NASOLABIAL FOLD WAS TREATED WITH 4 VIALS OF HYLENEX, WARM COMPRESSES, AND NITROGLYCERIN. THE PATIENT'S CAPILLARY REFILL RETURNED TO NORMAL SHORTLY THEREAFTER. HCP REPORTED CONTINUED IMPROVEMENT 12 HOURS POST HYLENEX TREATMENT HCP REPORTED PROPER ASPIRATION TECHNIQUE WAS FOLLOWED.

  Patient problems: Erythema; Obstruction/Occlusion

  MAUDE report 24866795 ↗
• InjuryMar 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE HEALTHCARE PROVIDER (HCP) INJECTED 1ML OF EVOLYSSE FORM INTO A PATIENT'S LIPS. ON (B)(6) 2026, THE PATIENT NOTICED SOME FILLER OOZING FROM HER BOTTOM LIP, THOUGH SHE DENIED MANIPULATING THE AREA HERSELF. THE HCP RECOMMENDED SHE APPLY ICE TO THE SITE INTERMITTENTLY. AS OF (B)(6) 2026, THE PATIENT WAS OUT OF THE COUNTRY AND UNABLE TO ATTEND AN OFFICE VISIT. ON (B)(6) 2026, THE HCP CONTACTED THE PATIENT AGAIN TO ARRANGE A FOLLOW-UP. THE PATIENT REPORTED THAT PRIOR TO LEAVING THE COUNTRY, THE FILLER HAD OOZED FROM HER BOTTOM LIP, CAUSING A BURNING SENSATION AND SWELLING. WHILE ABROAD, SHE WAS PRESCRIBED A FIVE-DAY COURSE OF ANTIBIOTICS DUE TO CONCERNS ABOUT A LOCALIZED INFECTION. CURRENTLY, THE PATIENT HAS A HARDENED LUMP ON ONE SIDE OF HER BOTTOM LIP. THE REPORTING HCP HAS NOT YET EVALUATED THE PATIENT IN PERSON.

  Patient problems: Fluid Discharge; Local Reaction; Skin Burning Sensation; Skin Infection

  MAUDE report 24669875 ↗
• InjuryMar 10, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE HEALTHCARE PROVIDER (HCP) INJECTED 1ML OF EVOLYSSE FORM INTO A PATIENT'S LIPS. ON (B)(6) 2026, THE PATIENT NOTICED SOME FILLER OOZING FROM HER BOTTOM LIP, THOUGH SHE DENIED MANIPULATING THE AREA HERSELF. THE HCP RECOMMENDED SHE APPLY ICE TO THE SITE INTERMITTENTLY. AS OF (B)(6) 2026, THE PATIENT WAS OUT OF THE COUNTRY AND UNABLE TO ATTEND AN OFFICE VISIT. ON (B)(6) 2026, THE HCP CONTACTED THE PATIENT AGAIN TO ARRANGE A FOLLOW-UP. THE PATIENT REPORTED THAT PRIOR TO LEAVING THE COUNTRY, THE FILLER HAD OOZED FROM HER BOTTOM LIP, CAUSING A BURNING SENSATION AND SWELLING. WHILE ABROAD, SHE WAS PRESCRIBED A FIVE-DAY COURSE OF ANTIBIOTICS DUE TO CONCERNS ABOUT A LOCALIZED INFECTION. CURRENTLY, THE PATIENT HAS A HARDENED LUMP ON ONE SIDE OF HER BOTTOM LIP. THE REPORTING HCP HAS NOT YET EVALUATED THE PATIENT IN PERSON.

  Patient problems: Local Reaction; Skin Infection

  MAUDE report 24563441 ↗
• InjuryFeb 3, 2026Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 THE HCP REPORTED INJECTING 1CC OF EVOLYSSE FORM INTO THE LIPS AND NASOLABIAL FOLDS OF A PATIENT. BY (B)(6) 2025, THE PATIENT EXPERIENCED DISCOLORATION IN THE UPPER LIP WHICH THEY DESCRIBED AS "DUSKY" ALONG WITH EYE TWITCHING AND PAIN. MASSAGE TEMPORARILY IMPROVED THE DISCOLORATION, BUT SYMPTOMS RETURNED WHEN STOPPED. ON (B)(6) 2026, THE HCP SUSPECTED A VASCULAR OCCLUSION AND ADMINISTERED 10 VIALS OF AMPHADASE, RESULTING IN MINIMAL IMPROVEMENT; MASSAGE, HEAT, AND ASPIRIN WERE PRESCRIBED. ANOTHER HCP PERFORMED AN ULTRASOUND OF THE PATIENT ON (B)(6) 2026 AND DIAGNOSED THE PATIENT WITH BILATERAL VASCULAR OCCLUSIONS IN BOTH ORAL COMMISSURES WITH REDNESS EXTENDING FROM THE CORNER OF THE MOUTH TO THE CORNER OF THE EYE. THE HCP INJECTED 2 VIALS OF HYALURONIDASE AND PATIENT EXPERIENCED AN IMPROVEMENT OF SYMPTOMS. THE PATIENT'S SYMPTOMS RESOLVED AS OF (B)(6) 2026.

  Patient problems: Erythema; Obstruction/Occlusion; Pain; Skin Discoloration; Twitching

  MAUDE report 24248675 ↗
• InjuryJan 13, 2026Off-Label Use

  ON DECEMBER 22, 2025 THE HCP REPORTED INJECTING 1CC OF EVOLYSSE FORM INTO THE LIPS AND NASOLABIAL FOLDS OF A PATIENT. BY (B)(6) 2025, THE PATIENT EXPERIENCED DISCOLORATION IN THE UPPER LIP WHICH THEY DESCRIBED AS "DUSKY" ALONG WITH EYE TWITCHING AND PAIN. MASSAGE TEMPORARILY IMPROVED THE DISCOLORATION, BUT SYMPTOMS RETURNED WHEN STOPPED. ON (B)(6) 2026, THE HCP SUSPECTED A VASCULAR OCCLUSION AND ADMINISTERED 10 VIALS OF AMPHADASE, RESULTING IN MINIMAL IMPROVEMENT; MASSAGE, HEAT, AND ASPIRIN WERE PRESCRIBED. ANOTHER HCP PERFORMED AN ULTRASOUND OF THE PATIENT ON (B)(6) 2026 AND DIAGNOSED THE PATIENT WITH BILATERAL VASCULAR OCCLUSIONS IN BOTH ORAL COMMISSURES WITH REDNESS EXTENDING FROM THE CORNER OF THE MOUTH TO THE CORNER OF THE EYE. THE HCP INJECTED 2 VIALS OF HYALURONIDASE AND PATIENT EXPERIENCED AN IMPROVEMENT OF SYMPTOMS. THE PATIENT'S SYMPTOMS RESOLVED AS OF (B)(6) 2026.

  Patient problems: Erythema; Pain; Reduced Blood Flow; Skin Discoloration; Twitching

  MAUDE report 24054514 ↗
• InjuryDec 3, 2025Off-Label Use; Off-Label Use

  THE HEATLHCARE PROFESSIONAL (HCP) REPORTED ADMINISTERING A DENTAL BLOCK WITH LIDOCAINE, CLEANSING THE LIPS WITH PURYCIN TOPICAL CLEANSER, AND THEN INJECTING LESS THAN ONE SYRINGE OF EVOLYSSE SMOOTH INTO THE LIPS OF THE PATIENT ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED BLISTERS ON THE LOWER LIP FOLLOWING CONTACT WITH A FAMILY MEMBER THAT ALSO HAD LIP BLISTERS, UPON RETURN FROM PUERTO RICO. THE PATIENT TESTED POSITIVE FOR IMPETIGO AND WAS TREATED WITH ANTIBIOTICS BY PRIMARY CARE PHYSICIAN. ON (B)(6), 2025, THE PATIENT EXPERIENCED A FIRM LUMP TO THE LEFT SIDE OF HER UPPER LIP. NO PAIN, REDNESS, OR DISCOLORATION WAS OBSERVED. THE PATIENT SELF MEDICATED WITH CLARITIN; NO IMPROVEMENT IN SYMPTOMS. A SEPARATE HCP PRESCRIBED A MEDROL PACK, ZYRTEC, AND FAMOTIDINE; PATIENT STARTED THIS TREATMENT REGIMEN ON (B)(6) 2025. THE PATIENT EXPERIENCED A FULL RESOLUTION OF SYMPTOMS UNTIL COMPLETION OF THE TREATMENT REGIMEN, THEN THE SYMPTOMS RETURNED. ON (B)(6) 2025; THE PRODUCT WAS DISSOLVED WITH 1 VIAL OF HYLENEX TO THE UPPER AND LOWER LIPS FOLLOWING ADMINISTRATION OF A LIDOCAINE NUMBING BLOCK; A SUBSEQUENT TREATMENT WITH HYLENEX WAS PERFORMED ON (B)(6) 2025. THE SYMPTOMS PERSIST.

  Patient problems: Blister; Skin Infection; Subcutaneous Nodule

  MAUDE report 23705626 ↗
• InjuryNov 24, 2025Off-Label Use; Off-Label Use

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED ADMINISTERING A DENTAL BLOCK WITH LIDOCAINE, CLEANSING THE LIPS WITH PRUMYCIN TOPICAL CLEANSER, AND THEN INJECTING LESS THAN ONE SYRINGE OF EVOLYSSE SMOOTH INTO THE LIPS OF THE PATIENT ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT EXPERIENCED BLISTERS ON THE LOWER LIP FOLLOWING CONTACT WITH A FAMILY MEMBER THAT ALSO HAD LIP BLISTERS, UPON RETURN FROM PUERTO RICO. THE PATIENT TESTED POSITIVE FOR IMPETIGO AND WAS TREATED WITH ANTIBIOTICS BY PRIMARY CARE PHYSICIAN. ON (B)(6) 2025, THE PATIENT EXPERIENCED A FIRM LUMP TO THE LEFT SIDE OF HER UPPER LIP. NO PAIN, REDNESS, OR DISCOLORATION WAS OBSERVED. THE PATIENT SELF MEDICATED WITH CLARITIN; NO IMPROVEMENT IN SYMPTOMS. A SEPARATE HCP PRESCRIBED A MEDROL PACK, ZYRTEC, AND FAMOTIDINE; PATIENT STARTED THIS TREATMENT REGIMEN ON (B)(6) 2025. THE PATIENT EXPERIENCED A FULL RESOLUTION OF SYMPTOMS UNTIL COMPLETION OF THE TREATMENT REGIMEN, THEN THE SYMPTOMS RETURNED. ON (B)(6) 2025; THE PRODUCT WAS DISSOLVED WITH 1 VIAL OF HYLENEX TO THE UPPER AND LOWER LIPS FOLLOWING ADMINISTRATION OF A LIDOCAINE NUMBING BLOCK; A SUBSEQUENT TREATMENT WITH HYLENEX WAS PERFORMED ON (B)(6) 2025. THE SYMPTOMS PERSIST.

  Patient problems: Blister; Skin Infection; Subcutaneous Nodule

  MAUDE report 23633737 ↗
• InjuryNov 21, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE LIPS OF A PATIENT. THE PATIENT EXPERIENCED LUMPS. THE HCP DISSOLVED THE LUMPS WITH HYALURONIDASE WITH SOME DIFFICULTY. THE MANUFACTURER PROVIDED SYRINGE WAS NOT USED.

  Patient problems: Inflammation; Nodule

  MAUDE report 23620917 ↗
• InjuryNov 11, 2025Off-Label Use; Off-Label Use

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE LIPS OF A PATIENT. PATIENT HAD EXTREME LIP SWELLING INITIALLY. THEN ON (B)(6) 2025, APPROXIMATELY TEN (10) DAYS POST INJECTION, PATIENT EXPERIENCED HARD NODULES IN LIPS. ON (B)(6) 2025, THE HCP DISSOLVED THE PRODUCT WITH TWO (2) VIALS OF HYLENEX. THE HCP SUSPECTED THE NODULES WERE INFECTIOUS IN NATURE AND PRESCRIBED AN UNKNOWN ANTIBIOTIC. THE PATIENT EXPERIENCED A COMPLETE RESOLUTION OF SYMPTOMS.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23528177 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE MARIONETTE LINES AND PERI ORAL AREA OF A PATIENT. APPROXIMATELY TEN (10) DAYS POST INJECTION, ON (B)(6) 2025, THE PATIENT EXPERIENCED HARD NODULES IN ALL AREAS TREATED. ON (B)(6) 2025, THE HCP DISSOLVED THE PRODUCT WITH 2 VIALS OF HYLENEX. THE PATIENT EXPERIENCED A FULL RESOLUTION OF SYMPTOMS.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23527958 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE MARIONETTE LINES AND NASOLABIAL FOLDS OF A PATIENT. ON (B)(6) 2025, APPROXIMATELY TEN (10) DAYS POST INJECTION, PATIENT EXPERIENCED HARD NODULES IN ALL AREAS TREATED. ON (B)(6) 2025, THE HCP DISSOLVED THE PRODUCT WITH ONE 1 VIAL OF HYLENEX. THE PATIENT EXPERIENCED A FULL RESOLUTION OF SYMPTOMS.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23527946 ↗
• InjuryOct 31, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH EVOLYSSE FORM IN THE LIPS. APPROXIMATELY TWO (2) WEEKS POST INJECTION, THE PATIENT EXPERIENCED LUMPS AND BUMPS IN THE LIPS LIKE THE PRODUCT DID NOT SETTLE. THE HCP DISSOLVED THE PRODUCT AND THE SYMPTOMS RESOLVED.

  Patient problems: Local Reaction

  MAUDE report 23439694 ↗
• InjuryOct 31, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH EVOLYSSE FORM IN THE LIPS. APPROXIMATELY TWO (2) WEEKS POST INJECTION, THE PATIENT EXPERIENCED LUMPS AND BUMPS IN THE LIPS LIKE THE PRODUCT DID NOT SETTLE. THE HCP DISSOLVED THE PRODUCT AND THE SYMPTOMS RESOLVED.

  Patient problems: Local Reaction

  MAUDE report 23439658 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE LIPS OF A PATIENT. PATIENT HAD EXTREME SWELLING INITIALLY. THEN APPROXIMATELY TEN (10) DAYS POST INJECTION, PATIENT HAD HARD MASSES/NODULES IN LIPS.. THE HCP DISSOLVED THE PRODUCT WITH TWO (2) VIALS OF HYLENEX AND ANTIBIOTICS. PATIENT HAD A COMPLETE RESOLUTION OF SYMPTOMS.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23430154 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE FORM INTO THE MARIONETTE LINES AND NASOLABIAL FOLDS OF A PATIENT. APPROXIMATELY TEN (10) DAYS POST INJECTION, PATIENT HAD HARD MASSES/NODULES IN ALL AREAS TREATED. THE HCP DISSOLVED THE PRODUCT WITH ONE 1 VIAL OF HYLENEX AND PATIENTS HAD A COMPLETE RESOLUTION OF SYMPTOMS.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23430153 ↗