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

Catalog Number	95661
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported that the patient was injected in the lips with 0.7 ml of juvéderm® vollure¿ xc.Four weeks later, the patient was injected in the lips with 0.3 ml of juvéderm® vollure¿ xc.Within the next 3 months, the patient experienced possible granulomas (biopsy was not provided), one large nodule on the right lower lip, one small nodule in corner of the left lower lip, and a small nodule above the left lower lip.The patient was treated with hylenex and again a week later.Event is ongoing.This emdr is being submitted for 2nd injection.
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.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.

• 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: 20510238
• Report Number: 3005113652-2024-00659
• Device Sequence Number: 7983927
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(17)250209(11)230309(10)1000578420
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 02/09/2025
• Device Catalogue Number: 95661
• Device Lot Number: 1000578420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Race: White