MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661DB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	03/12/2025
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.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 that a patient was injected in the lips with juvéderm volbella® xc and juvéderm vollure® xc.Hcp later reported that the patient was injected in fulls lips with 0.9 cc juvéderm vollure® xc, then two weeks later, in the lips for touchup with 0.2 cc of juvéderm volbella® xc.The patient experienced hard, swollen, tender lips at the site of injection.At first it was at the site of the juvéderm volbella® xc injections but then all the sites.There was medical intervention provided, prednisone 60 mg taper (12 days) + doxycycline 100 mg bid (14 days) po, 2 units of hylenex in the largest nodule right upper corner lip.150 units hdl c indo/ epi total to dissolve the lip filler.The symptoms are ongoing.This is the same event and the same patient reported under patient identifier (b)(6) ((b)(4)).This emdr is being submitted for the suspect product, juvéderm vollure® xc.

• Brand Name: JUVEDERM VOLLURE XC
• 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: 21877564
• Report Number: 3005113652-2025-00380
• Device Sequence Number: 18055786
• Product Code: LMH
• UDI-Device Identifier: 10840228302817
• UDI-Public: (01)10840228302817(10)1001654413(11)240412(17)260312
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 03/12/2026
• Device Catalogue Number: 95661DB
• Device Lot Number: 1001654413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHROID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White