MAUDE Adverse Event Report: PRINGY JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Nodule (4551)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with one syringe each of juvéderm voluma® xc and juvéderm vollure¿ xc.Two weeks before, the patient went in for consult and they ¿had a nodule in their lip from rha product.¿ approximately three months post injections, the patient went in ¿with a few nodules however not exactly where voluma or vollure was placed.¿ the following month the patient had ¿periodontal and sinus surgery.¿ then the following month, the patient was treated with 300u hylenex® and prescribed antibiotics and prednisone.The day after, the patient was treated again with 100u hylenex®to dissolve.Four days later, the hcp saw the patient again and they suspected the patient may have an undiagnosed auto-immune disorder.Hcp said patient looks like they have bilateral perioral cellulitis and advised the patient to go to er and request iv antibiotics.Symptoms are ongoing.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) additionally reported injecting the patient with 1ml of juvéderm voluma® xc in the ¿jawline and chin shadows,¿ and with 1ml of juvéderm vollure¿ xc in the nl folds, lips and marionette lines (glazing).¿ approximately three weeks post injections, there was a ¿small blep of vollure superficial, 18g needle product expressed easily.No problems.Happy with results.About three months later, the patient was injected with botox® and had lip nodules small not tender, hcp thought to be from prior rha.That same week the patient had 2 dental implants and experienced an abscess and the infection spread to filler.The patient was treated with amox.Two days later, the patient had an ultrasound in office and the results were severe tissue swelling.Two weeks later, over a phone call the patient advised the hcp they had an ¿ov nodule new under chin.¿ the patient was treated with medrol dose pack.The following week, the patient experienced ¿severe swelling in the lower face, lips, jawline, and under right eye.Could not feel nodules due to severe swelling.¿ the patient was treated with 300 units hylenex®, kenalog 40mg im cipro500mg bid x 10 days, and xyzal 5mg bid.¿ the patient had another ultrasound in office and the results were also severe tissue swelling.The following day, much improved the swelling went down.The patient was treated again with ¿100u hylenex® more focal to nodules.¿ the next day, the patient experienced ¿severe hip pain and body aches worsening.¿ hcp advised to stop cipro and was prescribed ¿doxycycline 100mg bid.¿ the following week, the patient had a video follow up and was looking better and feeling better.Six days later, the patient¿s entire face was swollen, redness, tenderness, pain with eye movement appeared to have possible periorbital cellulitis.The hcp sent the patient to the er and spoke to er dr.The patient was given solumedrol + started on iv antibiotics, seen by infectious disease doctor.The patient was hospitalized for 2 nights.Discharged on linezolid for 10 days.Six more days later, follow up in the office and the swelling was much better no generalized symptoms.No redness or pain but had many nodules, lips jawline, cheeks (left only).Patient said they never had filler there.The patient was treated with ¿hylenex® 150u to nodules injected directly.Prednisone tapering dose over 7 days.¿ six days later, the patient was treated again with ¿hylenex®100u injected directly nodules improving large nodule left cheek 2x1 cm and 1mg of kenalog.¿ four days later, the patent had a video follow up and symptoms continued to improve.Symptoms are ongoing.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a2, a6, b3, b5, b6, b7, c1, c3, d1, d4, h4, h6, h8, h10.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23843427
• Report Number: 3005113652-2025-01158
• Device Sequence Number: 9526777
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)1002893505(11)241030(17)260930
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 95661
• Device Lot Number: 1002893505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White