JUVEDERM VOLUX XC 20073770Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10840228300073), received between Feb 8, 2023 and Aug 7, 2026 — classified as 47 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient was injected with JUVÉDERM® VOLUX¿ XC. The patient experienced an "abscess.¿ Event status was unknown.

  Patient problems: Abscess

  MAUDE report 50181522 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE JAWLINE WITH JUVÉDERM® VOLUX¿ XC. A WEEK LATER, THE PATIENT REPORTED ¿PAIN AND LUMP¿ ON THEIR MANDIBLE THAT FELT ¿JULES ROOT CANAL.¿ THE PATIENT WAS TREATED WITH AUGMENTIN FOR 10 DAYS AND A MEDROL DOSEPAK. THERE WAS CONCERN THAT ¿FILLER GOT INTO THE GLAND OR A POSSIBLE DELAYED ONSET INFLAMMATORY STATE.¿ EVENT WAS ONGOING.

  Patient problems: Nodule

  MAUDE report 25610771 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 2ML IN THE CHEEKS AND WITH 1ML IN THE CHIN & PREJOWLS WITH JUVÉDERM VOLUMA® XC, AND WITH 3ML IN THE GONIAL ANGLES & JAWLINE OF JUVÉDERM VOLUX¿ XC. THE PATIENT WAS CONCOMITANTLY INJECTED WITH 64 UNITS OF BOTOX®. APPROXIMATELY EIGHT MONTHS LATER, THE PATIENT EXPERIENCED A ¿DELAYED INFLAMMATORY REACTION TO VOLUX¿.¿ THE HCP ¿MENTIONED THAT THEY ARE TREATING ACCORDING TO ASDS GUIDELINES.¿ SYMPTOMS ARE ONGOING.

  Patient problems: Inflammation

  MAUDE report 25364868 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CHEEKS AND PREAURICULAR WITH 2.7 ML OF JUVÉDERM® VOLUMA¿ XC AND IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC. TWO AND HALF MONTHS LATER, THE PATIENT WAS INJECTED IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC AND IN THE CHEEKS WITH 2 ML OF SKINVIVE¿ BY JUVÉDERM®. FOUR MONTHS LATER, THE PATIENT EXPERIENCED ¿DELAYED ONSET NODULES¿ AT THE INJECTION SITES. FOR THE NEXT 11 MONTHS, THE PATIENT HAD MULTIPLE TREATMENTS WITH HYLENEX, PREDNISONE, AND ANTIHISTAMINES. TWO MONTHS POST-ONSET, AN AEROBIC + ANAEROBIC WOUND CULTURE WAS PERFORMED, RESULTING AS ¿NEGATIVE.¿ THE EVENT PARTIALLY RESOLVED AT THE END OF THE TREATMENT ROUND BUT RESURFACED 15 MONTHS LATER. THAT MONTH, THE PATIENT WAS TREATED WITH 4 COURSES OF ANTIBIOTICS (DOXYCYCLINE, CLARITHROMYCIN, AND AUGMENTIN), PREDNISONE TAPER, ANTIHISTAMINES, AND 5FU. EVENT WAS ONGOING. THIS FILE CAPTURED THE INITIAL JUVÉDERM® VOLUX¿ XC.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25338387 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THEY WERE INJECTED WITH 2 MLS OF JUVÉDERM VOLUMA® XC AND 2 MLS OF JUVÉDERM® VOLUX¿ XC INTO THE JAW AREAS. ABOUT A YEAR LATER, PATIENT BEGAN EXPERIENCING NODULES. ROUGHLY ANOTHER YEAR PASSED WHEN PATIENT STARTED HAVING THE AREA TREATED WITH HYLENEX, BUT THE ISSUE HAS REMAINED.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25306369 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CHEEKS AND PREAURICULAR WITH 2.7 ML OF JUVÉDERM® VOLUMA¿ XC AND IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC. TWO AND HALF MONTHS LATER, THE PATIENT WAS INJECTED IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC AND IN THE CHEEKS WITH 2 ML OF SKINVIVE¿ BY JUVÉDERM®. FOUR MONTHS LATER, THE PATIENT EXPERIENCED ¿DELAYED ONSET NODULES¿ AT THE INJECTION SITES. FOR THE NEXT 11 MONTHS, THE PATIENT HAD MULTIPLE TREATMENTS WITH HYLENEX, PREDNISONE, AND ANTIHISTAMINES. TWO MONTHS POST-ONSET, AN AEROBIC + ANAEROBIC WOUND CULTURE WAS PERFORMED, RESULTING AS ¿NEGATIVE.¿ THE EVENT PARTIALLY RESOLVED AT THE END OF THE TREATMENT ROUND BUT RESURFACED 15 MONTHS LATER. THAT MONTH, THE PATIENT WAS TREATED WITH 4 COURSES OF ANTIBIOTICS (DOXYCYCLINE, CLARITHROMYCIN, AND AUGMENTIN), PREDNISONE TAPER, ANTIHISTAMINES, AND 5FU. EVENT WAS ONGOING. THIS FILE CAPTURED THE ADDITIONAL JUVÉDERM® VOLUX¿ XC.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25217486 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Nodule

  MAUDE report 24833720 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 3 SYRINGES OF JUVÉDERM® VOLUX¿ XC TO THE JAWLINE AS WELL AS JUVÉDERM® VOLUMA® XC AND AN UNSPECIFIED JUVÉDERM® ULTRA PRODUCT. PATIENT DEVELOPED SWELLING AND PAIN THAT "COMES AND GOES" AT THE INJECTION SITE OF JUVÉDERM® VOLUX¿ XC. HCP NOTED NODULES ARE MORE PRESENT ON THE LEFT SIDE THAN THE RIGHT SIDE AND APPEAR TO BE ROUGHLY 2.5CM X 0.5CM. SYMPTOMS ARE ONGOING. THIS RELATES TO JUVÉDERM® VOLUX¿ XC.

  Patient problems: Nodule

  MAUDE report 24818122 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  .HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 3 SYRINGES OF JUVÉDERM® VOLUX¿ XC TO THE JAWLINE AS WELL AS JUVÉDERM® VOLUMA® XC AND AN UNSPECIFIED JUVÉDERM® ULTRA PRODUCT. PATIENT DEVELOPED SWELLING AND PAIN THAT "COMES AND GOES" AT THE INJECTION SITE OF JUVÉDERM® VOLUX¿ XC. HCP NOTED NODULES ARE MORE PRESENT ON THE LEFT SIDE THAN THE RIGHT SIDE AND APPEAR TO BE ROUGHLY 2.5CM X 0.5CM. SYMPTOMS ARE ONGOING. THIS RELATES TO JUVÉDERM® VOLUX¿ XC.

  Patient problems: Nodule

  MAUDE report 24818114 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED IN THE JAWLINE WITH 3 SYRINGES OF JUVÉDERM® VOLUX¿ XC. ELEVEN MONTHS LATER, THE PATIENT EXPERIENCED AN ¿INFLAMMATORY RESPONSE¿ ON THE LEFT SIDE OF THE JAWLINE. THAT DAY, THE PATIENT WAS TREATED WITH IBUPROFEN. THE FOLLOWING DAY, THE PATIENT WAS TREATED WITH HYLENEX. THE EVENT RESOLVED 3 DAYS LATER.

  Patient problems: Inflammation

  MAUDE report 24653985 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC AND JUVÉDERM® VOLUMA¿ XC. THE PATIENT EXPERIENCED ¿GRANULOMAS¿ IN THE JAWLINE. BIOPSY WAS NOT PROVIDED. THE GRANULOMAS WERE EXCISED. EVENT IS ONGOING. THIS FILE CAPTURED THE JUVÉDERM® VOLUX¿ XC.

  Patient problems: Granuloma

  MAUDE report 24389208 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2MLS OF JUVÉDERM® VOLUX¿ XC INTO THE BILATERAL GONIAL ANGLE AND PRE AURICULAR SPACE. PATIENT ALSO INJECTED WITH 0.5CCS OF JUVÉDERM® ULTRA INTO THE LIPS. ABOUT A MONTH AFTER INJECTION, PATIENT BEGAN EXPERIENCING SWELLING AND PAIN IN THE RIGHT JAW. PATIENT REPORTED DIFFICULTY BITING INTO HARDER FOOD ITEMS. PATIENT WAS PRESCRIBED PREDNISONE 40MG FOR THREE WEEKS. SYMPTOMS REPORTEDLY DISSIPATED ABOUT A MONTH LATER, BUT ULTIMATELY RETURNED WITHIN TWO WEEKS. TWO DAYS AFTER THE RETURN OF SYMPTOMS, THE AREA WAS DISSOLVED WITH 150U HYLENEX AND PATIENT WAS PRESCRIBED ANOTHER 10 DAYS OF PREDNISONE 40MG. 2 WEEKS LATER, PATIENT DENIED ANY PRESENT SYMPTOMS.

  Patient problems: Inflammation

  MAUDE report 23779854 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT IN THE CHIN, MARIONETTE LINES, PREJOWL, AND JAWLINE WITH 1 SYRINGE OF JUVÉDERM® VOLUX¿ XC. THE PATIENT WAS CONCOMITANTLY INJECTED WITH 2 SYRINGES OF REVANESSE® VERSA¿+. FIVE MONTHS LATER, THE PATIENT DEVELOPED A ¿PERSISTENT PEA-SIZED NODULE¿ ON THE MID-JAWLINE ON THE LEFT SIDE. THE NODULE WAS DISSOLVED WITH 210 U OF HYALURONIDASE. TWO MONTHS LATER, THE PATIENT RETURNED WITH A ¿SMALLER THAN PEA-SIZE NODULE¿ MID-TO-MEDIAL JAWLINE ON THE RIGHT SIDE. THE PATIENT WAS TREATED WITH 190 U OF HYALURONIDASE, AND A NEEDLE WAS USED TO BREAK IT UP MORE. THE PATIENT REPORTED BEING ¿UNABLE TO STOP TOUCHING IT OR PLAYING WITH IT.¿ THIS LED TO FEELING IT ¿BREAK UP AND THEM COME BACK TOGETHER.¿ THE PATIENT FELT ¿IRRITATION FROM EXCESSIVELY TOUCHING IT.¿ TWO WEEKS LATER, THE PATIENT WAS TREATED WITH ANOTHER 100 U OF HYALURONIDASE (50 U DILUTED 1:1 WITH BACTERIOSTATIC SALINE). THE WAS MORE ¿SIGNIFICANT SWELLING¿ AFTER THE LATEST ROUND. TWO DAYS LATER, AT THE PATIENT¿S INSURANCE, ANOTHER 150 U OF HYALURONIDASE WAS GIVEN. THE NODULE REMAINED ¿THE SIZE OF A GRAIN OF RICE.¿ EVENT IS ONGOING.

  Patient problems: Nodule

  MAUDE report 23650228 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 1 ML IN THE CHIN AND 1 ML IN THE JAWLINE OF JUVÉDERM® VOLUX¿ XC. PATIENT DEVELOPED GRANULOMAS BUT NO HISTOLOGY TO CONFIRM (NODULES WERE LARGE LIKE GRANULOMAS, BUT WERE WELL-CONFINED BY A FIBROUS CAPSULE LIKE NODULES NEAR INJECTION SITES). PATIENT SELF PRESCRIBED TWO MEDROL DOSEPAKS. THE PATIENT HAD 2 SESSIONS OF HYLENEX, 2 CC HYLENEX FIRST SESSION AND 3 CC SECOND SESSION. IT WAS FURTHER REPORTED PATIENT RECENTLY EXPERIENCED A FLARE UP OF A GRANULOMA AFTER SINUS COLD, DEEMED NOT RELATED TO THE DEVICE.

  Patient problems: Granuloma; Nodule; Viral Infection

  MAUDE report 23501272 ↗
• InjuryOct 31, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLUX¿ XC IN THE TEMPLES. PATIENT EXPERIENCED A VASCULAR OCCLUSION IN THE TEMPLES 48 HOURS POST INJECTION. HCP NOTED THEY ARE FOLLOWING "VASCULAR OCCLUSION PROTOCOL" FOR TREATMENT. SYMPTOMS ARE ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23441708 ↗
• InjuryJul 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A CLINICAL PATIENT WAS INJECTED IN THE TEMPLES WITH 2.1ML OF JUVÉDERM VOLUMA® XC, IN THE JAWLINE WITH 1.8ML OF JUVÉDERM VOLUX¿ XC, IN THE NASOLABIAL FOLDS WITH 0.7ML OF JUVÉDERM VOLLURE¿ XC AND IN THE INFRAORBITAL HOLLOWING WITH 0.7ML OF JUVÉDERM VOLBELLA® XC. THE PATIENT CONCOMITANTLY TAKES PROZAC, ROSUVASTATIN AND PARAGUARD IUD. THAT SAME DAY, THE PATIENT EXPERIENCED A ¿VASCULAR OCCLUSION FROM INJECT OF JUVEDERM VOLUX INTO OR APPROXIMATE TO THE RIGHT FACIAL ARTERY NEAR THE ANTEGONIAL NOTCH.¿ THAT SAME DAY THE PATIENT EXPERIENCED ¿RIGHT LOWER FACE HEMATOMA PAIN, RIGHT LOWER FACE HEMATOMA SWELLING, AND RIGHT LOWER FACE HEMATOMA ECCHYMOSIS CAUSED BY STUDY DEVICE PROCEDURE.¿ THE PATIENT WAS IMMEDIATELY TREATED WITH 1200MG OF HYLENEX® AND ASPIRIN. THE NEXT DAY THE PATIENT WAS TREATED AGAIN WITH 600MG OF HYLENEX®. THE FOLLOWING DAY WITH 450MG OF HYLENEX® AND ACETAMINOPHEN-CODEINE 325 MG TABLET. THE NEXT DAY THE PATIENT WAS TREATED AGAIN WITH 450MG OF HYLENEX®, PERIDEX MOUTHWASH AND PREDNISONE. THREE DAYS AFTER THE LAST SYMPTOMS, THE PATIENT EXPERIENCED ¿ORAL BUCCAL MUCOSA ULCERATION CAUSED BY MASSAGE AND UPPER AND LOWER EYELID SWELLING CAUSED BY H

  Patient problems: Obstruction/Occlusion

  MAUDE report 22566386 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC IN THE JAWLINE. THE PATIENT CALLED TO REPORT THAT THEY HAD EXPERIENCED SWELLING AND SORENESS ALONG THEIR JAWLINE. THE PATIENT WAS SEEN IN THE OFFICE AND AT THE END OF LAST MONTH HAD AN ABSCESS ON THEIR RIGHT JAWLINE AND AN ABSCESS ON THEIR LEFT JAWLINE. THIS WAS COMBINED WITH SWELLING AND PAIN. THE HCP TREATED THE PATIENT WITH .3CC HYALURONIDASE ON THEIR RIGHT ABSCESS AND .5CC¿S ON THEIR LEFT ABSCESS. THE SWELLING WENT DOWN. A FEW DAYS LATER, THE PATIENT WAS SEEN BACK IN THE OFFICE IN WHICH A CULTURE TEST WAS DONE ON EACH ABSCESS WHICH CAME BACK ¿NO GROWTH.¿ HCP PRESCRIBED THE PATIENT DOXYCYCLINE FOR 10 DAYS CONSISTING OF 2 PILLS A DAY. THE PATIENT RETURNED TO THE OFFICE RECENTLY AND THE SWELLING WAS A LITTLE BETTER THAN THE LAST VISIT AND WAS INJECTED WITH .3CC¿S HYALURONIDASE ON THE RIGHT ABSCESS ON .5CC¿S ON THE LEFT ABSCESS. THE PATIENT MADE A FINAL VISIT TO THE OFFICE AND THERE WAS A LITTLE LESS SWELLING AND OVERALL, THEY LOOKED BETTER, AND THE HCP INJECTED THE PATIENT WITH .3CC¿S HYALURONIDASE ON THEIR RIGHT ABSCESS ON .5CC¿S ON THEIR LEFT ABSCESS. SYMPTOMS ARE ONGOING.

  Patient problems: Abscess

  MAUDE report 22532789 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE "JAWLINES" WITH THREE SYRINGES OF JUVÉDERM VOLUX¿ XC. ABOUT TWO WEEKS POST INJECTIONS, THE PATIENT EXPERIENCED AN "INFECTION" AT THE INJECTION SITES. THE PATIENT WAS TREATED WITH "DOXYCYCLINE 100 MG - TWO WEEK SUPPLY." APPROXIMATELY TWO WEEKS LATER THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED KEFLEX & BACTRIM. THE HCP ADVISED THE PATIENT "NOT TO USE MAKEUP BRUSHES BUT PATIENT USED MAKEUP BRUSHES ANYWAY." SYMPTOMS ARE ONGOING.

  Patient problems: Nodule; Unspecified Infection

  MAUDE report 22299565 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER EMDR-89994. THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS INJURY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6); (EMDR-89996) AND (B)(6); (EMDR-89998). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVEDERM VOLUX XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162819 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER (B)(6). THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS UNEXPECTED ADVERSE DRUG EXPERIENCE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER(B)(6) (B)(4) AND (B)(6) (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVEDERM VOLUX XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162754 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM VOLUX¿ XC INTO THE BILATERAL JAWLINE AND EXPERIENCED MILD ALLERGIC REACTION ON BILATERAL JAWLINE AND ITCHY RAISED RASH FIVE DAYS LATER AND WAS GIVEN ANTIHISTAMINE. TWO DAYS LATER, PATIENT WAS TREATED WITH 300 UNITS OF HYLENEX IN BILATERAL JAWLINE AND ALL THE FILLER "SEEMED" TO BE COMPLETELY DISSOLVED. THE NEXT DAY, PATIENT REPORTED RASH WAS SPREADING "UPWARDS TOWARDS CHEEKS" AND PATIENT WAS PRESCRIBED TOPICAL STEROIDS AND A MEDROL DOSE PACK SYMPTOMS. SYMPTOMS ARE ON-GOING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22145393 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH JUVÉDERM VOLUMA® XC INTO THE HANDS. TWO AND HALF MONTHS LATER, PATIENT WAS INJECTED WITH 2 ML OF JUVÉDERM® VOLUX¿ XC IN THE JAWLINE AND 1 ML OF JUVÉDERM VOLBELLA® XC IN THE TEAR TROUGH. THREE MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC IN THE JAWLINE. THE PATIENT DEVELOPED AN INFLAMMATORY RESPONSE AT THE SITE OF PREVIOUS JUVÉDERM VOLUMA® XC INJECTION IN THE HANDS ALONG WITH SWELLING IN THE AREAS WHERE JUVÉDERM® VOLUX¿ XC HAS BEEN INJECTED. THE PATIENT WAS INITIALLY TREATED WITH ORAL ANTIBIOTICS AND STEROIDS. ABOUT TWO MONTHS LATER, PATIENT WAS ADMINISTERED A COURSE OF ORAL PREDNISONE. ABOUT TWO MONTHS LATER, ANOTHER ROUND OF PREDNISONE AND INJECTIONS OF HYLENEX INTO THE AFFECTED AREAS ON TWO OCCASIONS. A MONTH LATER, ANOTHER HYLENEX INJECTIONS WERE ADMINISTERED. PATIENT CONTINUE TO HAVE RECURRENT EPISODES OF SWELLING. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER: (B)(6) (EMDR-(B)(4) (EMDR (B)(4), (B)(6) (EMDR (B)(4) (EMDR (B)(4), AND (B)(6) (EMDR (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE FORTH SUSPECT PRODUCT,

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 22098879 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 CC OF JUVÉDERM® VOLBELLA® XC, 3 CC OF JUVÉDERM® VOLUMA® XC, AND 2 CC OF JUVÉDERM® VOLUX¿ XC INTO THE JOWL AND PRE-JOWL AREA. TWO MONTHS LATER, THE PATIENT BEGAN TO EXPERIENCE SWELLING IN THE PRE-JOWL AREA, "NO FEVER, JUST SORE, RED AND TENDER". HCP PRESCRIBED AUGMENTIN. PATIENT WAS SEEN BY THE HCP TEN DAYS LATER WHERE THEY INJECTED THE PATIENT WITH 2.5ML OF HYLENEX AND ANOTHER 7 DAYS OF AUGMENTIN. FOUR DAYS LATER, PATIENT WAS INJECTED WITH ANOTHER 3ML OF HYLENEX. ELEVEN DAYS LATER, THE PATIENT WAS INJECTED WITH ANOTHER 2ML OF HYLENEX TO THE LEFT SIDE AND 1 CC TO THE RIGHT SIDE "THAT HAD JUST STARTED APPEARING NODULES". SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6); (EMDR-82032) AND (B)(6); (EMDR-82030). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT JUVÉDERM® VOLUX¿ XC.

  Patient problems: Nodule

  MAUDE report 21885189 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLUX¿ XC IN THE POSTERIOR JAWLINE BILATERALLY. PATIENT IS EXPERIENCING LUMPS ON BOTH SIDES, THE RIGHT SIDE IS DESCRIBED AS "RED, SWOLLEN, SORE, ENCAPSULATED", THE LEFT SIDE LUMPS ARE "NOWHERE NEAR AS BAD". PATIENT IS ALSO EXPERIENCING ITCHING. HCP PLACED THE PATIENT ON DOXYCYCLINE THE DAY AFTER SYMPTOM ONSET. HCP SWITCHED THE DOXYCYCLINE TO AMOXICILLIN AND FOUR DAYS LATER AND INJECTED THE PATIENT WITH HYLENEX. SYMPTOMS ARE ONGOING. A 25G 1.5" CANNULA WAS USED. THIS WAS THE INITIAL USE OF THE SYRINGE.

  Patient problems: Nodule

  MAUDE report 21877340 ↗
• InjuryApr 16, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, HEALTHCARE PROFESSIONAL STATED THAT THE PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® VOLUX¿ XC. POST INJECTION THE PATIENT EXPERIENCED PAIN, AND A VASCULAR OCCLUSION AT THE SITE OF INJECTION. THE PATIENT WOULD NOT SHAVE BEARD BECAUSE IT WAS HARD FOR THEM TO SEE SKIN CHANGES DURING OR EVENT POST INJECTION, PAIN WAS PERSISTENT. THE HCP INJECTED THE PATIENT 4 ROUNDS OF 1800 UNITS OF HYLENEX SOMETIMES TWICE A DAY. SYMPTOMS RESOLVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21850913 ↗