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	Abscess (1690)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected with 2mls of juvéderm® volux¿ xc into jawline, 4mls of juvéderm® voluma¿ xc(2mls in cheek and 2mls in chin/prejowl sulcus), 1ml of juvéderm® vollure¿ xc in the nasolabial folds, and 1ml of juvéderm® volbella¿ xc in the lips.A little over 4 months later, the patient would ultimately go to an urgent care center and was treated for "bilateral abscess on both masseters".The patient has not gone back to the injecting institution for evaluation at this time.Patient still currently has the filler in place.Events ongoing.This is the same event and the same patient reported under mdr id#(b)(4) (allergan complaint #(b)(4)), mdr id# (b)(4) (allergan complaint #(b)(4)), and mdr id# (b)(4) (allergan complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvéderm® vollure¿ xc.
Additional Manufacturer Narrative
Clarification to section c.Suspect product: lot number 963/2.Continued d.10.Concomitant therapies: juvéderm® volbella¿ xc.Continued h.6.Investigation code: b15, b17, b20.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
Additional information reported, patient had gone to multiple emergency rooms/treating institutions for the event.And received unspecified treatment at these.Patient had multiple ct scans over the course of a few months.The most recent ct scan about 4 months, after event onset was clear noting, no filler or abscess present.Healthcare professional unsure if the event has resolved.

• 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: 18069404
• Report Number: 3005113652-2023-00871
• Device Sequence Number: 20731467
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 09/02/2024
• Device Catalogue Number: 95661
• Device Lot Number: 1000544204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2022
• 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® VOLUX¿ XC, JUVÉDERM® VOLUMA¿ XC,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female