SKINVIVE BY JUVEDERM XC 1ML SAMPLE 98307DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10840228302763), received between Feb 9, 2026 and Apr 24, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 ML OF SKINVIVE¿ BY JUVÉDERM®. TWO MONTHS LATER, PATIENT WAS INJECTED IN THE LOWER CHEEK WITH ANOTHER 1 ML OF SKINVIVE¿ BY JUVÉDERM®. APPROXIMATELY 6 WEEKS LATER, PATIENT RECEIVED BOTULOTOXIN A (BOTOX®) IN THE GLABELLA. ONE MONTH LATER, PATIENT RETURNED TO THE INJECTOR WITH ¿SWELLING AND MINOR NODULES¿ AT THE INJECTION SITE. THE PATIENT HAD EXPERIENCED NON-DEVICE RELATED ¿COLD/FLU¿ AND THE EVENTS BEGAN AFTER THE ILLNESS. THE PATIENT WAS RECOMMENDED NSAID AND ANTIHISTAMINE FOR TREATMENT. THREE DAYS LATER, HYALASE TREATMENT WAS RECOMMENDED, BUT THE PATIENT DECLINED. FOUR DAYS LATER, A HYALASE TEST WAS PERFORMED ON THE FOREARM WITH NO REACTIONS. THE PROCESS CAUSED THE PATIENT TO HAVE AN ¿ANXIETY ATTACK/FEAR OF DEATH¿ AND WAS TAKEN BY AMBULANCE WHERE THEY WERE TREATED AS AN OUTPATIENT AND WENT HOME. EVENT WAS ONGOING. THIS RELATES TO THE SECOND INJECTION OF SKINVIVE¿ BY JUVÉDERM®.

  Patient problems: Anxiety; Nodule

  MAUDE report 24985490 ↗
• InjuryApr 1, 2026Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF SKINVIVE¿ BY JUVÉDERM® IN THE PERIORAL AREA, NASOLABIAL FOLDS, AND MARIONETTE LINES. PRE-TREATMENT INCLUDED ANESTHETIC CREAM.TWO DAYS POST INJECTIONS, THE PATIENT EXPERIENCED ¿REDNESS AND PALLOR IN THE AREA OF THE NASOLABIAL FOLD/ RIGHT CHEEK.¿ THREE DAYS LATER, THE PATIENT WAS TREATED WITH ASPIRIN AND HYLASE 300 U. TWO DAYS LATER THE PATIENT WAS TREATED AGAIN WITH HYLASE 450 U. THE EVENTS RESOLVED SEVEN DAYS POST SYMPTOM ONSET.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24756305 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  THE HCP ADDITIONALLY REPORTED INJECTING A PATIENT WITH 1ML OF SKINVIVE¿ BY JUVÉDERM® IN THE ¿RIGHT SIDE¿ OF THE FACE. ONE MONTH LATER, THE PATIENT WAS INJECTED WITH 2ML OF SKINVIVE¿ BY JUVÉDERM® ON BOTH SIDES OF THE FACE. APPROXIMATELY ONE MONTH LATER, THE PATIENT WENT IN FOR EXAMINATION COMPLAINING OF A NODULE AT THE EYE CORNERS AND CHEEKS. THE PATIENT WAS TREATED WITH HYALURONIDASE INTO THE NODULE. THE DOSE WAS 5-15U PER LESION.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24665052 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PERFORMING ¿A GOLD NEEDLE TREATMENT ON A PATIENT, AND AFTER THE HEALING PERIOD¿ WHICH WAS ONE AND HALF MONTH LATER, THE PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM®. THERE WERE NO ISSUES AFTER THE FIRST TREATMENT; THE PATIENT'S SKIN QUALITY SIGNIFICANTLY IMPROVED AND THERE WAS A NOTICEABLE REDUCTION IN WRINKLES. SOMETIME LATER, THE PATIENT RECEIVED A SECOND TREATMENT OF SKINVIVE¿ BY JUVÉDERM® AND AFTER THIS ¿SECOND APPLICATION, NODULES FORMED UNDER THE SKIN.¿ DESPITE ATTEMPTING DISSOLUTION PROCEDURES, THE DESIRED RESULT WAS NOT ACHIEVED. SYMPTOMS ARE ONGOING. THIS RECORD CAPTURED THE 1ST INJECTION.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24665047 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED SKINVIVE BY JUVÉDERM®, SINCE THEN, "PATIENT HAS HAD 3 VIRUSES AND NOW IS SHOWING DELAYED ONSET NODULES". SYMPTOMS ONGOING.

  Patient problems: Nodule

  MAUDE report 24433860 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT, WHO IS A HEALTHCARE PROFESSIONAL, REPORTED SELF-INJECTING IN THE MIDFACE WITH 1 SYRINGE OF SKINVIVE¿ BY JUVÉDERM®. THE NEXT DAY, THE PATIENT EXPERIENCED ¿BUMPS¿ SUPERFICIALLY, A ¿RED/PINKISH RASH,¿ AND ¿INFLAMED SKIN AND PUSTULES¿ AROUND/CLOSE TO THE INJECTION SITE, AT THE LEFT CHEEK. THE REDNESS REACHED 1 CM AROUND THE SITE. THE PATIENT WAS TREATED WITH DYE VL LASER, AND RED-LIGHT THERAPY. EVENT IS ONGOING.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299564 ↗