MAUDE Adverse Event Report: ALLERGAN (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 Code	Unspecified Infection (1930)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported being injected with two syringes of juvéderm vollure¿ xc in the jawline and chin area and one syringe of juvéderm voluma® xc in the lips and left-side of cheek area.One year later, patient experienced "burning, redness, inflammation, reacted immediately after injections".Patient additionally reported they (non-device related) "felt like it was not right, light sensitivity, dizziness, felt weird, fullness, brain fog, ears infected, facial pain" as well as "feeling strange, granulomas forming at injection sites, late onset reaction to ha, lumps, being diagnosed with (non-device related) pneumonia, sinusitis and a major illness".Patient received n unknown antibiotic and "flooded lower face lumps with hyaluronidase which burned and hurt so bad and did nothing to the lumps".Approximately 2 weeks later, patient was treated with more hyaluronidase, which they said made them "so sick from what felt like poison running through my body".Patient noted "every time i get sick or my immune system is compromised lumps form then go back down for a long time now resulting in my left-cheek and chin area puffing up" and the "filler lumps in lips are inflamed".Patient noted an mri was performed which "diagnosed type 2 inflammatory disease".Symptoms are ongoing.This captures the injection of juvéderm vollure¿ xc.
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.The event of "sinus infection, pneumonia, major illness", deemed not device related, is considered an unexpected adverse drug experience.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (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: 24866610
• Report Number: 9617229-2026-06708
• Device Sequence Number: 21470005
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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 Catalogue Number: 95661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White