MAUDE Adverse Event Report: 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 Codes	Unspecified Infection (1930); Nodule (4551)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification to h6: 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.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient in the "jawlines" with three syringes of juvéderm volux¿ xc.About two weeks post injections, the patient experienced an "infection" at the injection sites.The patient was treated with "doxycycline 100 mg - two week supply." approximately two weeks later the patient went to the emergency room and was prescribed keflex & bactrim.The hcp advised the patient "not to use makeup brushes but patient used makeup brushes anyway." symptoms are ongoing.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b5, b7, h6.
Event or Problem Description
Healthcare professional (hcp) additionally reported approximately two weeks after emergency room visit, the patient was treated with doxycycline.Two days later the hcp per formed an ¿¿i +d, hylenex®.¿ hcp noted, ¿inflammatory nodules started 2 wks after filler injections.Pt has had volbella + volluma in the past without issues.1st time with volux.Skin cleaned with alcohol, (illegible & chlorhexidine prior to injection.Injected jawline on bone & with cannula in so area, looked great for a couple weeks until tender nodules formed filler pushing to surface of skin & looked like a ¿pimple.¿ after 3 courses of antibiotics, i did puncture with 25g needle & was able to drain both pus & filler.Pt instantly reported relief.Added some hylenex® to hard areas and around jawline.F/u next day pt reports it¿s resolving & improved- will see patient for a f/u in office.Patient may have pigment/ induration problem in affected areas.That i will continue to treat as needed.¿ 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: 22299565
• Report Number: 3005113652-2025-00568
• Device Sequence Number: 21151005
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1000752347(11)231024(17)250924
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 09/24/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000752347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White