EVOLYSSE SMOOTH EVOF1S001Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03760172161271), received between Aug 19, 2025 and May 7, 2026 — classified as 45 injuries.

The most frequently reported specific device problem is “Off-Label Use” (32 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A HEALTHCARE PROVIDER REPORTED INJECTING 0.6CC OF EVOLYSSE SMOOTH INTO A FEMALE PATIENT IN THE LIPS USING A SUPERFICIAL, LINEAR THREADING TECHNIQUE WITH A 30 GAUGE NEEDLE. THE PATIENT EXPERIENCED SLIGHT BLANCHING IN THE UPPER RIGHT LIP TISSUE ALONG WITH A HEMATOMA. TREATMENT WITH ICE AND ARNICA WERE ADMINISTERED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SAME DAY AS THE INJECTION AT APPROXIMATELY 8:30 PM THE PATIENT NOTIFIED THE INJECTING PHYSICIAN AND REPORTED PAIN AND DISCOLORATION IN THE UPPER LIP AND PERIORAL AREA. THE PATIENT RETURNED TO THE OFFICE IMMEDIATELY AND A VASCULAR OCCLUSION WAS CONFIRMED BY THE HCP. SYMPTOMS INCLUDED DELAYED CAPILLARY REFILL, PAIN AND TISSUE BLANCHING. HEAT AND MASSAGE TO THE AFFECTED AREA WAS PERFORMED AND THE PATIENT WAS INJECTED WITH 2 VIALS OF HYLENEX. FOLLOWING TREATMENT, THE HCP OBSERVED THE SKIN COLOR AND CAPILLARY REFILL RETURNED TO NORMAL. THE PATIENT RETURNED HOME. ON (B)(6) 2026, THE PATIENT REPORTED HER SYMPTOMS HAD RETURNED AND A BLISTER HAD FORMED ON THE UPPER LIP. THE PATIENT WAS SENT FOR AN ULTRASOUND. THE HCP STATED THE ULTRASOUND SHOWED THE VASCULAR OCCLUSION WAS NOT FULLY RESOLVED. THE HCP INJECTED THE UPPER LIP

  Patient problems: Hematoma; Obstruction/Occlusion; Pain; Pallor; Skin Discoloration

  MAUDE report 25112166 ↗
• InjuryApr 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 A HEALTHCARE PROVIDER REPORTED INJECTING 0.6 CC OF EVOLYSSE SMOOTH INTO A FEMALE PATIENT IN THE LIPS USING A SUPERFICIAL, LINEAR THREADING TECHNIQUE WITH A 30 GAUGE NEEDLE. THE PATIENT EXPERIENCED SLIGHT BLANCHING IN THE UPPER RIGHT LIP TISSUE ALONG WITH A HEMATOMA. TREATMENT WITH ICE AND ARNICA WERE ADMINISTERED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SAME DAY AS THE INJECTION, AT APPROXIMATELY 8:30 PM, THE PATIENT NOTIFIED THE INJECTING PHYSICIAN AND REPORTED PAIN AND DISCOLORATION IN THE UPPER LIP AND PERIORAL AREA. THE PATIENT RETURNED TO THE OFFICE IMMEDIATELY AND A VASCULAR OCCLUSION WAS CONFIRMED BY THE HCP. SYMPTOMS INCLUDED DELAYED CAPILLARY REFILL, PAIN AND TISSUE BLANCHING. HEAT AND MASSAGE TO THE AFFECTED AREA WAS PERFORMED AND THE PATIENT WAS INJECTED WITH 2 VIALS OF HYLENEX. FOLLOWING TREATMENT, THE HCP OBSERVED THE SKIN COLOR AND CAPILLARY REFILL RETURNED TO NORMAL. THE PATIENT RETURNED HOME. ON THE (B)(6) 2026 THE PATIENT REPORTED HER SYMPTOMS HAD RETURNED AND A BLISTER HAD FORMED ON THE UPPER LIP. THE PATIENT WAS SENT FOR AN ULTRASOUND. THE HCP STATED THE ULTRASOUND SHOWED THE VASCULAR OCCLUSION WAS NOT FULLY RESOLVED. THE HCP INJECTED THE UPPER

  Patient problems: Blister; Hematoma; Obstruction/Occlusion; Pain; Pallor; Skin Discoloration

  MAUDE report 24967511 ↗
• InjuryMar 30, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.4CC OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT BY BACKFILLING THE PRODUCT INTO A BD SYRINGE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED BLANCHING AND PAIN AT THE WET/DRY BORDER ALONG WITH SIGNIFICANT BRUISING. THE HCP DETERMINED THE SYMPTOMS TO BE CONSISTENT WITH A VASCULAR OCCLUSION AND INJECTED THE PATIENT'S LIPS WITH 1 VIAL OF HYLENEX OVER THREE (3) INJECTIONS. THE AFOREMENTIONED TREATMENT WAS SUCCESSFUL IN TREATING THE VASCULAR OCCLUSION. AS OF (B)(6) 2026, ALL THE PATIENT'S SYMPTOMS HAVE RESOLVED; NO LONG-TERM EFFECTS WERE REPORTED.

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

  MAUDE report 24736291 ↗
• InjuryMar 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.4CC OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT BY BACKFILLING THE PRODUCT INTO A BD SYRINGE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED BLANCHING AND PAIN AT THE WET/DRY BORDER ALONG WITH SIGNIFICANT BRUISING. THE HCP DETERMINED THE SYMPTOMS TO BE CONSISTENT WITH A VASCULAR OCCLUSION AND INJECTED THE PATIENT'S LIPS WITH 1 VIAL OF HYLENEX OVER THREE (3) INJECTIONS. THE AFOREMENTIONED TREATMENT WAS SUCCESSFUL IN TREATING THE VASCULAR OCCLUSION. AS OF (B)(6) 2026, ALL THE PATIENT'S SYMPTOMS HAVE RESOLVED; NO LONG TERM EFFECTS WERE REPORTED.

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

  MAUDE report 24670476 ↗
• InjuryFeb 4, 2026Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2025 THE HCP REPORTING INJECTING EVOLYSSE SMOOTH INTO BOTH THE UPPER AND LOWER LIPS OF A PATIENT. BY NOVEMBER 28, 2025, THE PATIENT EXPERIENCED YELLOW CRUSTING ON HER LIPS. THE PATIENT WAS PRESCRIBED ANTIVIRALS WITH NO IMPROVEMENT. SHE WAS THEN PRESCRIBED THE FIRST MEDROL DOES STEROID PACK WITHOUT IMPROVEMENT. THE PATIENT WAS THEN TREATED WITH BACTROBAN (ANTIBIOTIC) AND A SECOND MEDROL STEROIDS DOSE PACK WITHOUT IMPROVEMENT. THE PRODUCT WAS DISSOLVED AND RESULTED IN A SIGNIFICANT IMPROVEMENT TO THE PATIENT. HOWEVER, THE PATIENT IS EXPERIENCING DISCOMFORT DUE TO AN IMPAIRED BARRIER WHICH IS BEING MANAGED WITH GABAPENTIN AND FLEXERIL. THE PATIENT IS EXPERIENCING REFERRED PAIN IN THE JAW AND SENSITIVITY IN THE LIPS. AS OF JANUARY 05, 2026 THE PATIENT'S LIPS HAVE RE-EPITHELIALIZED AND SYMPTOMS ARE IMPROVING. AS OF JANUARY 27, 2026, THE PATIENT HAS FULLY RECOVERED AND IS NO LONGER EXPERIENCING ANY PAIN SYMPTOMS.

  Patient problems: Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 24263521 ↗
• InjuryJan 23, 2026Off-Label Use

  ON NOVEMBER 14, 2025, THE HCP REPORTING INJECTING EVOLYSSE SMOOTH INTO BOTH THE UPPER AND LOWER LIPS OF A PATIENT. BY (B)(6) 2025, THE PATIENT EXPERIENCED YELLOW CRUSTING ON HER LIPS. THE PATIENT WAS PRESCRIBED ANTIVIRALS WITH NO IMPROVEMENT. SHE WAS THEN PRESCRIBED THE FIRST MEDROL DOES STEROID PACK WITHOUT IMPROVEMENT. THE PATIENT WAS THEN TREATED WITH BACTROBAN (ANTIBIOTIC) AND A SECOND MEDROL STEROIDS DOSE PACK WITHOUT IMPROVEMENT. THE PRODUCT WAS DISSOLVED AND RESULTED IN A SIGNIFICANT IMPROVEMENT TO THE PATIENT. HOWEVER, THE PATIENT IS EXPERIENCING DISCOMFORT DUE TO AN IMPAIRED BARRIER WHICH IS BEING MANAGED WITH GABAPENTIN AND FLEXERIL. THE PATIENT IS EXPERIENCING REFERRED PAIN IN THE JAW AND SENSITIVITY IN THE LIPS. AS OF (B)(6) 2026, THE PATIENT'S LIPS HAVE RE-EPITHELIALIZED AND SYMPTOMS ARE IMPROVING.

  Patient problems: Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 24171772 ↗
• InjuryDec 12, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL INJECTED 1CC OF EVOLYSSE SMOOTH INTO A PATIENT'S LIPS. ON (B)(6) 2025, THE PATIENT RECEIVED INJECTIONS OF TIRZEPATIDE AND VITAMIN B3, AFTER WHICH THEY EXPERIENCED SWELLING AT THE INJECTION SITE, AS WELL AS LIP SWELLING AND TINGLING. THAT SAME DAY, THE HEALTHCARE PROVIDER REFERRED THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE TREATMENT INCLUDED INTRAVENOUS EPINEPHRINE AND STEROIDS, FOLLOWED BY A 10-DAY COURSE OF ORAL STEROIDS. ON (B)(6) 2025, THE FINAL DAY OF ORAL STEROIDS, THE PATIENT AGAIN HAD SWOLLEN LIPS. THE PATIENT VISITED THEIR PRIMARY CARE PROVIDER (PCP) ON (B)(6) 2025, WAS PRESCRIBED ORAL STEROIDS, AND REFERRED TO AN ALLERGIST. THE PATIENT'S LIP SWELLING SUBSIDED ONCE ORAL STEROIDS WERE RE-STARTED.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23789359 ↗
• InjuryDec 9, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL INJECTED 1CC OF EVOLYSSE SMOOTH INTO A PATIENT'S LIPS. ON (B)(6) 2025, THE PATIENT RECEIVED INJECTIONS OF TIRZEPATIDE AND VITAMIN B3, AFTER WHICH THEY EXPERIENCED SWELLING AT THE INJECTION SITE, AS WELL AS LIP SWELLING AND TINGLING. THAT SAME DAY, THE HEALTHCARE PROVIDER REFERRED THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE TREATMENT INCLUDED INTRAVENOUS EPINEPHRINE AND STEROIDS, FOLLOWED BY A 10-DAY COURSE OF ORAL STEROIDS. ON (B)(6) 2025, THE FINAL DAY OF ORAL STEROIDS, THE PATIENT AGAIN HAD SWOLLEN LIPS. THE PATIENT VISITED THEIR PRIMARY CARE PROVIDER (PCP) ON (B)(6) 2025, WAS PRESCRIBED ORAL STEROIDS, AND REFERRED TO AN ALLERGIST. THE PATIENT'S LIP SWELLING SUBSIDED ONCE ORAL STEROIDS WERE RE-STARTED.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23759400 ↗
• InjuryNov 21, 2025Off-Label Use; Off-Label Use

  THE HEALTHCARE PROVIDER REPORTED INJECTING 0.2CC OF EVOLYSSE SMOOTH INTO BOTH SIDES OF THE UPPER LIP USING THE MANUFACTURER PROVIDED NEEDLE. IMMEDIATELY FOLLOWING THE PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED ASYMMETRICAL UPPER LIP EDEMA WITHOUT PAIN. THE CAPILLARY REFILL WAS NORMAL.

  Patient problems: Local Reaction

  MAUDE report 23620937 ↗
• 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 0.8ML OF EVOLYSSE SMOOTH INTO THE UPPER AND LOWER LIPS OF A PATIENT. APPROXIMATELY 8 WEEKS POST INJECTION, 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 23620920 ↗
• InjuryOct 31, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE HEALTHCARE PROVIDER REPORTED INJECTING A PATIENT WITH EVOLYSSE SMOOTH IN AND AROUND THE LIPS, PERIORAL LINES, AND BROWS. APPROXIMATELY ONE (1) WEEK POST INJECTION, THE PATIENT EXPERIENCED INDURATION AND SWELLING/INFLAMMATION AT ALL INJECTION SITES. THE HCP TREATED THE INDURATION WITH 30 UNITS OF HYALURONIDASE IN AREAS OF INJECTION SWELLING/IRIRITATION; HOWEVER, THE INFAMMATION/SWELLING PERSISTED.

  Patient problems: Local Reaction

  MAUDE report 23441953 ↗
• InjuryOct 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.3CC OF EVOLYSSE SMOOTH INTO THE SMILE LINES, CHEEKS, AND PERIORAL LINES. APPROXIMATELY TWO (2) WEEKS POST INJECTION, THE PATIENT EXPERIENCED VISIBLE LUMPS/NODULES IN THE LEFT CHEEK. THE HCP RECOMMENDED MASSAGE. PATIENT DECLINED TO HAVE PRODUCT DISSOLVED.

  Patient problems: Inflammation; Nodule

  MAUDE report 23415739 ↗
• InjuryOct 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING 0.35ML OF EVOLYSSE SMOOTH INTO BILATERAL CHEEKS. PATIENT EXPERIENCED "NOTICEABLE BUMP" THAT CAN BE FELT AND SEEN. HCP RECOMMENDED MASSAGE OF THE BUMP. THEN ON (B)(6) 2025 THE HCP INJECTED THE BUMP INTRADERMALLY WITH HYLENEX. THE PATIENT'S CONDITIONS IS REPORTED TO HAVE RESOLVED.

  Patient problems: Local Reaction

  MAUDE report 23415505 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROVIDER REPORTED INJECTING A PATIENT WITH EVOLYSSE SMOOTH IN AND AROUND THE LIPS, PERIORAL LINES, AND BROWS.. APPROXIMATELY ONE (1) WEEK POST INJECTION, THE PATIENT EXPERIENCED INDURATION AND SWELLING/INFLAMMATION AT ALL INJECTION SITES. THE HCP TREATED THE INDURATION WITH 30 UNITS OF HYALURONIDASE IN AREAS OF INJECTION SWELLING/IRRITATION, HOWEVER, THE INFLAMMATION/SWELLING PERSISTED.

  Patient problems: Local Reaction

  MAUDE report 23408710 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING 0.35ML OF EVOLYSSE SMOOTH INTO BILATERAL CHEEKS. PATIENT EXPERIENCED "NOTICEABLE BUMP" THAT CAN BE FELT AND SEEN. HCP RECOMMENDED MASSAGE OF THE BUMP. THEN ON (B)(6) 2025 THE HCP INJECTED THE BUMP INTRADERMALLY WITH HYLENEX. THE PATIENTS' CONDITIONS IS REPORTED TO HAVE RESOLVED.

  Patient problems: Local Reaction

  MAUDE report 23408441 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1.0CC OF EVOLYSSE SMOOTH INTO THE SMILE LINES, CHEEKS, AND PERIORAL LINES. APPROXIMATELY ONE (1) WEEK POST INJECTION, THE PATIENT EXPERIENCED VISIBLE LUMPS IN THE LEFT CHEEK. THE HCP RECOMMENDED MASSAGE. ON (B)(6) 2025, THE PATIENT STILL HAD NOTICEABLE LUMPS PRESENT. HCP TREATED PATIENT WITH APPROXIMATELY 15 UNITS OF HYLENEX AND SUCCESSFULLY DISSOLVED THE LUMP.

  Patient problems: Inflammation

  MAUDE report 23408440 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1.0CC OF EVOLYSSE SMOOTH INTO THE SMILE LINES, CHEEKS, AND PERIORAL LINES. APPROXIMATELY ONE (1) WEEK POST INJECTION, THE PATIENT EXPERIENCED VISIBLE LUMPS IN THE LEFT CHEEK. THE HCP RECOMMENDED MASSAGE. ON (B)(6) 2025, THE PATIENT STILL HAD NOTICEABLE LUMPS PRESENT. HCP TREATED PATIENT WITH APPROXIMATELY 15 UNITS OF HYLENEX AND SUCCESSFULLY DISSOLVED THE LUMP.

  Patient problems: Local Reaction

  MAUDE report 23408409 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.3CC OF EVOLYSSE SMOOTH INTO THE SMILE LINES, CHEEKS, AND PERIORAL LINES. APPROXIMATELY TWO (2) WEEKS POST INJECTION, THE PATIENT EXPERIENCED VISIBLE LUMPS IN THE LEFT CHEEK. THE HCP RECOMMENDED MASSAGE.

  Patient problems: Local Reaction

  MAUDE report 23408190 ↗
• InjuryOct 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE HEALTH CARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 2CC OF EVOLYSSE FORM INTO ONE SIDE OF THE PATIENT'S MIDFACE AND NASOLABIAL FOLDS. APPROXIMATELY ONE (1) MONTH POST INJECTION, THE PATIENT EXPERIENCED SWELLING. THE PATIENT WAS TREATED WITH TWO (2) ROUNDS OF HYALURONIDASE.

  Patient problems: Local Reaction

  MAUDE report 23380325 ↗
• InjuryOct 23, 2025Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.8CC OF EVOLYSSE SMOOTH AND FORM IN THE LIPS. PATIENT EXPERIENCED DELAYED SEVERE SWELLING, PAIN, AND LUMPS IN THE LIPS.

  Patient problems: Administration Site Reaction

  MAUDE report 23372254 ↗
• InjuryOct 23, 2025Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  HEALTH CARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.8CC OF SMOOTH IN THE LIPS. THE PATIENT EXPERIENCED LUMPS UNDER THE SKIN, BLUISH TINT TO THE UPPER LIP, AND PERIODIC SHOOTING PAIN AND SWELLING. ON (B)(6) 2025 THE COMPLAINANT REPORTED CONTINUING DISCOMFORT AND FIRMNESS/LUMPS IN THE LIPS, CONSISTENT WITH AN INFLAMMATORY RESPONSE.

  Patient problems: Inflammation; Local Reaction

  MAUDE report 23372240 ↗
• InjuryOct 23, 2025Off-Label Use; Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.4 MLS OF EVOLYSSE SMOOTH IN THE UPPER LIP. APPROXIMATELY TWO (2) HOURS POST TREATMENT THE PATIENT EXPERIENCED SEVERE SWELLING OF THE UPPER LIP WHICH WORSENED THROUGHOUT THE EVENING. THE PATIENT WAS TREATED WITH BENDRYL, PEPCID, CLARITIN, AND 40MG OF PREDNISONE. THE FOLLOWING MORNING, THE PATIENT'S SYMPTOMS SIGNIFICANTLY IMPROVED.

  Patient problems: Local Reaction

  MAUDE report 23372239 ↗
• InjuryOct 23, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  HEALTH CARE PROFESSIONAL REPORTED INJECTING 0.2CC OF SMOOTH INTO THE LIPS OF A PATIENT. THE PATIENT EXPERIENCED BRUISING, IMMEDIATE SWELLING, AND DISCOLORATION IN THE AREA INJECTED. THE HCP ASSESSED CAPILLARY REFILL AND REPORTED IT WAS MORE THAN 3 SECONDS. THE PATIENT WAS TREATED WITH A MASSAGE WITH ARNICA THEN THE CAPILLARY REFILL WAS REASSESSED, BUT WAS STILL SLOW. THE HCP INJECTED 1 VIAL OF HYLENEX TO DISSOLVE THE PRODUCT. ONE DAY (1) POST TREATMENT THE HCP INJECTED ANOTHER 1.5 VIALS OF HYLENEX DUE TO SLOW CAPILLARY REFILL. AS OF (B)(6) 2025, THE PATIENT SYMPTOMS HAVE RESOLVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23372238 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEATLH CARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 2CC OF EVOLYSSE FORM INTO ONE SIDE OF THE PATIENT'S MIDFACE AND NASOLABIAL FOLDS. APPROXIMATELY ONE (1) MONTH POST INJECTION, THE PATIENT EXPERIENCED SWELLING. THE PATIENT WAS TREATED WITH TWO (2) ROUNDS OF HYALURONIDASE.

  Patient problems: Swelling/ Edema

  MAUDE report 23351085 ↗
• InjuryOct 20, 2025Off-Label Use; Off-Label Use

  HEALTH CARE PROFESSIONAL REPORTED INJECTING 0.8CC OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT. APPROXIMATELY 4 DAYS POST INJECTION PATIENT EXPERIENCED LUMPS IN THE LIPS. THE HCP REPORTED THERE WERE NO EMERGENT SIGNS AND NO EXCESSIVE TENDERNESS, HARDNESS, BLANCHING, OR REDNESS.

  Patient problems: Local Reaction

  MAUDE report 23336403 ↗