MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUX XC 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	20073770
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
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.Abbvie is unable to confirm with the healthcare professional; therefore, additional event, product, or patient details are not attainable.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) 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 hematoma¿ the symptoms are ongoing.
Additional Manufacturer Narrative
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.Additional, corrected, and/or changed data: c1, c3, d1, d4, h4, h6.
Event or Problem Description
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 hematoma¿ the symptoms are ongoing.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• 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: 22566386
• Report Number: 3005113652-2025-00663
• Device Sequence Number: 21152975
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1000864996(11)231122(17)251022
• Combination Product (Y/N): Y
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000864996
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 66 KG