MAUDE Adverse Event Report: PRINGY JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected in each temple with 1cc of juvéderm voluma® xc, and with juvéderm vollure¿ xc with 0.7cc in the right side zygoma and 0.30cc in the left side.Approximately two weeks post injections the hcp saw the patient ¿for a persistent 7/10 nonradiating pressure like headache, worse on right side and with bending forward.¿ an ultrasound will be performed ¿because the hcp believes there is a venous occlusion.¿ symptoms are ongoing.This is the same event and the same patient reported under patient identifier (b)(6) (emdr-(b)(4).This emdr is being submitted for the suspect product, 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.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a2, a3a, b2, b3, b5, b6, b7, c1, c3, d1, d4, h4, h6, h8, h10.
Event or Problem Description
Healthcare professional additionally reported, the same day the patient was injected they experienced ¿compression of deep temporal artery + vein by us with sluggish flow in the ¿r & l sided temporal ha.¿ two weeks later, the hcp performed an ultrasound and the results showed, ¿compression of r deep temporal artery and vein causing decreased blood flow.¿ that same the patient was treated with ¿hylenex® injection cannula/ deep space.¿ one week later, a ¿repeat us on r temple improvement of ta/tv blood flow hylenex® x 1 vial us guided injection cannula to left temple for residual/ mild l sided ha.¿ seven days later, the symptoms fully resolved.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 21668005
• Report Number: 3005113652-2025-00268
• Device Sequence Number: 8228475
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)1001556509(11)240419(17)260319
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 04/02/2025

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: 03/19/2026
• Device Catalogue Number: 95661
• Device Lot Number: 1001556509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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: 53 YR
• Patient Sex: Female