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

Catalog Number	95661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected with two syringes of juvéderm® voluma¿ xc in the cheeks and two syringes of juvéderm® vollure¿ xc and in the marionette lines and chin.Approximately 2 months later, the patient developed 5-6 inflammatory nodules at injection sites.Nodules were accompanied by redness and swelling, but no itchiness or pain.Patient was treated with minocycline and 20 mg prednisone.Symptoms showed improvement over the first week.This is the same event and the same patient reported under mdr id# 3005113652-2023-00466 (abbvie complaint #pr (b)(4).Mdr id# 3005113652-2023-00465 (abbvie complaint #pr (b)(4).This mdr is being submitted for the suspect product, juvéderm® vollure¿ xc.
Additional Manufacturer Narrative
Suspect product: lot number 963/3.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.
Event or Problem Description
Additionally, patient developed bluish discoloration along of inflammatory nodule 3 days after injection.Two months later, patient was treated with prednisone 20mg.7 days later, patient was treated with minocycline 50mg bid and a week later with prednisone for 7 more days.Symptoms resolved a month later.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17172922
• Report Number: 3005113652-2023-00467
• Device Sequence Number: 7360338
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 12/30/2023
• Device Catalogue Number: 95661
• Device Lot Number: 1000505584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2022
• 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: JUVÉDERM® VOLUMA¿ XC; NATIVE PATH COLLAGEN SUPPLEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female