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

Catalog Number	20073770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	03/14/2025
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.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.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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, a3a, a5, a6, b5, h8.
Event or Problem Description
Healthcare professional(hcp) reported that patient was injected with 0.5cc of juvéderm® volbella® xc in the lips, 3 cc of juvéderm® voluma® xc in the cheeks, and 1.8cc of juvéderm® volux¿ xc into the jowl and pre-jowl areas.Two months later, the patient developed swelling in the pre-jowl area, no fever, just sore, red and tender.Hcp prescribed the patient with augmentin.Six days later, hcp injected the patient with 3ml of hylenex to the left side nodule and another 7 days of augmentin was prescribed.Two days later, patient was injected with another 3ml of hylenex to the left side nodule.Eleven days later, the patient was injected with another 2ml of hylenex to the left side and 1 ml to the right side where new nodules appeared.Ten days later, hcp injected the patient with another 2ml of hylenex to the left side nodule, and 1ml of hylenex to the right-side nodule.Hcp clarified later that the symptoms are only at the site of the juvéderm® volux¿ xc injection (prejowl sulcus).Symptoms are ongoing.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• 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): 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: 21885189
• Report Number: 3005113652-2025-00384
• Device Sequence Number: 3434616
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1000713754(11)230925(17)250825
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 04/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000713754
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 09/25/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White