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

Catalog Number	20073770
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/19/2025
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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting a patient with juvéderm® volux¿ xc in the temples.Patient experienced a vascular occlusion in the temples 48 hours post injection.Hcp noted they are following "vascular occlusion protocol" for treatment.Symptoms are ongoing.
Additional Manufacturer Narrative
Information about this case was previous submitted in mfr report #3005113652-2025-00966.All information will be consolidated into this mdr.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, changed, and/or corrected data: a2, a3, b3, b5, b6, b7, section c, d4, d6a, h4, h6, h8.
Event or Problem Description
Additionally, the healthcare professional reported that the patient was also injected in the hairline.The next day, the patient reported "discomfort, bruise, and pressure" and the patient was advised to take aspirin 81 mg and a warm compress.The next day, the patient awoke with "blisters/pimples and was treated with doxycycline 100 mg and viagra 50 mg.The event resolved a month later.

• 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: 23441708
• Report Number: 3005113652-2025-00975
• Device Sequence Number: 8552298
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1002350432(11)240821(17)260721
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 07/21/2026
• Device Catalogue Number: 20073770
• Device Lot Number: 1002350432
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Race: White