JUVEDERM VOLUMA XC 94640Recalls & reported problems

Summary

The FDA's MAUDE database contains 672 adverse event reports that list this exact device (DI 10888628000018), received between Feb 12, 2015 and Sep 18, 2026 — classified as 513 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (62 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 672 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Off-Label Use

  Patient reported they were injected with 1ml of of JUVÉDERM® VOLUMA¿ XC into the nasolabial folds. Two days later patient reported left side swelling in the cheek from the top to the chin and their eye was swollen shut with mild pain. Patient noted they had an infection. 3 days after onset, patient was prescribed Cefuroxime Axetil 500mg for 7 days. The infection was reportedly "gone" but they still have mild swelling and facial asymmetry.

  Patient problems: Unspecified Infection

  MAUDE report 50820273 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that 1 mL of JUVÉDERM® VOLUMA¿ XC in the chin, 0.5 mL of JUVÉDERM® VOLBELLA¿ XC in the lips, and 1 mL of JUVÉDERM® Ultra XC. The patient experienced one large, delayed onset nodules on both sides of chin, two small, delayed onset nodules on the left lower lip, and three small, delayed onset nodules on the left upper lip. Recently the HCP reported performing a physical examination and treating patient with 5-FU. This was the initial use of the syringe. An additional follow-up will be provided. Symptoms are ongoing.Additionally, the patient reported an adverse event with an unspecified JUVÉDERM® XC product and stated that a healthcare professional was asked to evaluate the lumps. The patient reported four areas of delayed-onset granulomas on the face following treatment approximately five months earlier, involving the upper lip, lower lip, and chin. The patient¿s lips were injected with JUVÉDERM VOLBELLA® XC, and the chin was injected with JUVÉDERM VOLUMA® XC. The HCP injected a product to help reduce swelling, and the patient was also prescribed Zyrtec and Pepcid.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50809235 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that a patient reported that a patient was injected in the CK1, CK2, and CK 3 using JUVÉDERM® VOLUMA¿ XC and JUVÉDERM® VOLLURE¿ XC The patient developed nodules in the marionette.Additionally, the healthcare professional reported that the patient was injected with JUVÉDERM® VOLUMA¿ XC in the CK1, CK2, and CK3, and 1 mL of JUVÉDERM® VOLLURE¿ XC in the M1, M2, M3 The patient developed nodules and tenderness. The HCP treated the patient with hylenex a year ago, and the next treatment was 5 months ago. The symptoms have resolved.

  Patient problems: Nodule

  MAUDE report 50803085 ↗
• InjurySep 16, 2026Improper or Incorrect Procedure or Method; Migration

  Following an aesthetic injection complication, multiple in-person and telemedicine assessments and filler-dissolving treatments were completed. Treatment history included hyaluronic acid filler injections to the deep temple and lateral cheek, with prior filler placements in the cheeks, temples, and under-eye areas by other providers. Persistent concerns involve subtle right upper-eyelid fullness and a small superficial vein near the outer eye, although significant improvement and no visual disturbance, pain, swelling, skin changes, tearing, dryness, inflammation, or hypervascularity were reported. Examination identified soft, non-tender, non-red fullness visible only with upward eyelid traction; imaging associated the area with a herniated infraorbital fat pad and showed no filler. Laser treatment may be considered if the superficial vein remains cosmetically bothersome.

  Patient problems: Obstruction/Occlusion; Subcutaneous Nodule

  MAUDE report 50789175 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported a patient was injected with 1ml of JUVÉDERM VOLUMA® XC into the cheek and 1ml of JUVÉDERM VOLBELLA® XC. Botox was also injected. Patient later experienced an allergic reaction that made them itchy all over their body. Patient called an ambulance two days after injection. Patient also went to see their primary care physician two days later and was prescribed antibiotics and steroids. Event ongoing.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50265071 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional (HCP) reported injecting a patient with two syringes of JUVÉDERM VOLUMA® XC in the cheeks and one syringe of JUVÉDERM VOLLURE¿ XC off label in the neck. About ten months later, the patient experienced ¿one nodule under right eye and three nodules on neck. Patient was treated with Hylenex® and had a follow up appointment two weeks after. Symptoms status is unknown.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50176388 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported a patient who was injected with 7 mL of JUVÉDERM® VOLUMA¿ XC in the cheek, and chin area. The patient was also injected with 2 mL of JUVÉDERM® VOLUX¿ XC in the cheek and injection sites and jawline at gonial angle 0.5 ml per side. Post injection the patient contacted the HCP regarding the right side between their lips and chin that was very sore after the injection. The HCP reassured the patient that it was likely filler, and it needed to settle. The HCP instructed them not to press or manipulate the filler and that it could take few weeks to settle. Recently the lump on the right side of their chin is now swollen and painful. The HCP requested the patient come for a visit. The HCP prescribed the patient doxycycline for upper respiratory infection. Also were treated with doxycycline which they prescribed for seven days and prescribed the patient to take more Prednisone 60mg for 3 days, 40mg for 3 days, 20 mg for 3 days and 10 mg for 3 days.

  Patient problems: Bacterial Infection

  MAUDE report 50116898 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported a patient who was injected with 7 mL of JUVÉDERM® VOLUMA¿ XC in the cheek, and chin area. The patient was also injected with 2 mL of JUVÉDERM® VOLUX¿ XC in the cheek and injection sites and jawline at gonial angle 0.5 ml per side. Post injection the patient contacted the HCP regarding the right side between their lips and chin that was very sore after the injection. The HCP reassured the patient that it was likely filler, and it needed to settle. The HCP instructed them not to press or manipulate the filler and that it could take few weeks to settle. Recently the lump on the right side of their chin is now swollen and painful. The HCP requested the patient come for a visit. The HCP prescribed the patient doxycycline for upper respiratory infection. Also were treated with doxycycline which they prescribed for seven days and prescribed the patient to take more Prednisone 60mg for 3 days, 40mg for 3 days, 20 mg for 3 days and 10 mg for 3 days.

  Patient problems: Nodule

  MAUDE report 50116857 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported injecting a patient in the midface with 2 syringes of JUVÉDERM® VOLUMA¿ XC and in the lips with JUVÉDERM® VOLLURE¿ XC. Ten days later, the patient experienced ¿swelling.¿ At 3 weeks, the patient felt ¿significant lumps and bumps.¿ The patient was advised to see their primary care physician who did not find any abnormalities. The patient started antihistamines that month. Two months later, the patient was treated with 150 units of Hylenex, and the antihistamines were restarted. Ten days later, the events had improved, with the lower lip no longer bumpy, and most of the swelling in the upper lip. Event was ongoing.This file captured the JUVÉDERM® VOLUMA¿ XC.

  Patient problems: Inflammation; Subcutaneous Nodule

  MAUDE report 50063479 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060740 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060699 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported they were injected with one syringe of JUVÉDERM VOLBELLA® XC in the tear throughs, ocularis, and in the middle underneath the eye area. patient also received 1ml of JUVÉDERM VOLUMA® XC into the marionette lines and 2mls of JUVÉDERM VOLUMA® XC into the temples. Patient noted that immediately after injection, they experienced "three big bumps in the eye area, indentation, caused disfigurement" and bilateral cystic acne on the eyelids soon after. Patient underwent two hyaluronidase injections approximately three and four weeks after the injection. Patient also received another 0.55mls of JUVÉDERM VOLUMA® XC into the cheeks. About another two weeks later, patient was injected with more JUVÉDERM VOLUMA® XC in an unspecified area that "reignited the lump and resulted in big as ever like a big mosquito bite." Patient reports event has been very stressful and is being evaluated by a plastic surgeon. The healthcare professional later informed AbbVie that the event was more of a "placement" and "settling" issue, noting that the left side is not settle properly and the issue was more prevalent there. Healthcare professional used pate in addition to the hyaluronidase injection

  Patient problems: Anxiety; Skin Disorders; Subcutaneous Nodule

  MAUDE report 50038351 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported they were injected with one syringe of JUVÉDERM VOLBELLA® XC in the tear throughs, ocularis, and in the middle underneath the eye area. patient also received 1ml of JUVÉDERM VOLUMA® XC into the marionette lines and 2mls of JUVÉDERM VOLUMA® XC into the temples. Patient noted that immediately after injection, they experienced "three big bumps in the eye area, indentation, caused disfigurement" and bilateral cystic acne on the eyelids soon after. Patient underwent two hyaluronidase injections approximately three and four weeks after the injection. Patient also received another 0.55mls of JUVÉDERM VOLUMA® XC into the cheeks. About another two weeks later, patient was injected with more JUVÉDERM VOLUMA® XC in an unspecified area that "reignited the lump and resulted in big as ever like a big mosquito bite." Patient reports event has been very stressful and is being evaluated by a plastic surgeon. The healthcare professional later informed AbbVie that the event was more of a "placement" and "settling" issue, noting that the left side is not settle properly and the issue was more prevalent there. Healthcare professional used pate in addition to the hyaluronidase injection

  Patient problems: Anxiety; Skin Disorders; Subcutaneous Nodule

  MAUDE report 50038349 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported they were injected with one syringe of JUVÉDERM VOLBELLA® XC in the tear throughs, ocularis, and in the middle underneath the eye area. patient also received 1ml of JUVÉDERM VOLUMA® XC into the marionette lines and 2mls of JUVÉDERM VOLUMA® XC into the temples. Patient noted that immediately after injection, they experienced "three big bumps in the eye area, indentation, caused disfigurement" and bilateral cystic acne on the eyelids soon after. Patient underwent two hyaluronidase injections approximately three and four weeks after the injection. Patient also received another 0.55mls of JUVÉDERM VOLUMA® XC into the cheeks. About another two weeks later, patient was injected with more JUVÉDERM VOLUMA® XC in an unspecified area that "reignited the lump and resulted in big as ever like a big mosquito bite." Patient reports event has been very stressful and is being evaluated by a plastic surgeon. The healthcare professional later informed AbbVie that the event was more of a "placement" and "settling" issue, noting that the left side is not settle properly and the issue was more prevalent there. Healthcare professional used pate in addition to the hyaluronidase injection

  Patient problems: Anxiety; Skin Disorders; Subcutaneous Nodule

  MAUDE report 50038333 ↗
• InjuryJul 27, 2026Improper or Incorrect Procedure or Method

  Healthcare professional reported a patient was injected in the cheek with "JUVÉDERM®¿VOLUMA¿ XC", patient presented immediate discoloration, which looked like a bruise, but also looked like an occlusion. The discoloration was "flooded with Hylenex" and "just looked like a bruise afterwards". It is unknown if the event is ongoing.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50036645 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 2.3 ML IN TEMPLES, CHEEKS, PRE AURICULAR AND LIPS WITH JUVÉDERM®¿VOLUMA¿ XC , "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Urinary Tract Infection

  MAUDE report 25828769 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 2.3 ML IN TEMPLES, CHEEKS, PRE AURICULAR AND LIPS WITH JUVÉDERM®VOLUMA¿ XC, "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Inflammation

  MAUDE report 25828755 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS. THE PATIENT HAS DELAYED NON-INFLAMMATORY NODULE. ADDITIONALLY, A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED WITH 1CC EACH SIDE INTO THE LATERAL CHEEKS. HCP ADMINISTERED AN ULTRASOUND AND THE RESULTS WERE NON-INFLAMMATORY, AND GRANULOMA. THE PATIENT WAS PRESENTED WITH DELAYED ONSET NODULES. THE HCP TREATED THE PATIENT WITH HYLENEX 2 TIMES. SYMPTOMS HAVE NOT RESOLVED.

  Patient problems: Granuloma

  MAUDE report 25653328 ↗
• 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 JUVÉDERM® VOLUMA¿ XC.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25217485 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM VOLUMA® XC IN THE BILATERAL CHEEKS AT THE START OF THIS YEAR. 3 MONTHS LATER THE PATIENT WAS PRESENTED WITH REDNESS AND EDEMA ON THE BILATERAL CHEEKS AND UNDER EYES. THERE WAS NO PAIN. THE HCP TREATED THE PATIENT WITH HYLENEX AS WELL AS A MEDROL DOSE PACK FOR 6 DAYS. THE PATIENT RETURNED TO THE OFFICE A FEW WEEKS LATER AND THE SYMPTOMS HAVE GOTTEN BETTER BUT NOT COMPLETELY RESOLVED.

  Patient problems: Inflammation

  MAUDE report 25161253 ↗
• InjuryMay 13, 2026Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT 9 MONTHS AGO WAS INJECTED WITH JUVÉDERM VOLUMA® XC IN THE INFRA BROW. RECENTLY THE PATIENT WAS PRESENTED WITH NODULES. NO PAIN OR REDNESS. THE PATIENT WAS ADMINISTERED WITH HYLENEX. THE PATIENT RETURNED AND WAS ADMINISTERED AS WELL AS MASSAGE. THE SYMPTOMS HAVE NOT BEEN RESOLVED.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25160602 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE ORAL COMMISSARS AND CHEEKS WITH 1 CC OF JUVÉDERM® VOLUMA¿ XC. THREE MONTHS LATER, THE PATIENT EXPERIENCED ¿AN INFLAMMATORY NODULE.¿ THE HEALTHCARE PROFESSIONAL BELIEVED THE EVENT WAS A BIOFILM DUE TO IT ONLY BEING ON ONE SIDE WHERE A HARD CAPSULE COULD BE FELT. BIOPSY WAS NOT PROVIDED. THAT DAY, THE PATIENT WAS GIVEN AN ANTIBIOTIC, PREDNISONE AND THEN HYLENEX. EVENT WAS ONGOING. THE SAME EVENT OCCURRED 3 TIMES THE PATIENT RECEIVED JUVÉDERM® VOLUMA¿ XC.

  Patient problems: Unspecified Infection

  MAUDE report 25150488 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH JUVÉDERM VOLUMA® XC. TEN MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLLURE¿ XC. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLBELLA® XC. HCP REPORTED THE PATIENT WAS EXPERIENCING "HYPERSENSITIVITY". HCP LATER REPORTED PATIENT WAS EXPERIENCING DELAYED ONSET NODULES IN THE LIPS, NASOLABIAL FOLDS, CHEEKS, AND MARIONETTE LINES. SYMPTOMS BEGAN 6 DAYS POST A MICRO NEEDLING SESSION WITH PLATED EXOSOMES. PATIENT WAS TREATED WITH 2 DISSOLUTION TREATMENTS 12 DAYS APART. HCP LATER REPORTED PATIENT HAD "PERIORBITAL EDEMA DURING FLARE". PATIENT VISITED URGENT CARE AND HAD BLOODWORK DONE WHICH DID NOT SHOW AN INFECTION. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. THE PACKAGED NEEDLE WAS USED. THIS RELATES TO JUVÉDERM VOLUMA® XC.

  Patient problems: Nodule

  MAUDE report 24957795 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON-DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24866792 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON-DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24866143 ↗