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

Catalog Number 95661

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm voluma® xc.The reporter has declined to provide allergan permission to contact their healthcare professional, therefore additional event, product, or patient details are not attainable.The event of abscess is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient reported being injected in the cheek area with one syringe of juvéderm voluma® xc and mid-face area with one syringe of juvéderm vollure¿ xc.A week later, the patient experienced ¿bone pain and facial abscess¿ in fleshy area of the cheeks.The patient was treated with bactrim 4 days later, with cipro 4 days later, and with iv antibiotics when the patient was hospitalized the following day.The patient underwent surgery 3 days later and was hospitalized for 5 days.An mri and ct testing was administered that revealed ¿inflation of the cheek bones." patient further reported they were "just in the hospital again." the event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00717 (allergan complaint # (b)(4)).This mdr is being submitted for the suspect product, juvéderm vollure¿ xc.

Event Description

Patient reported an additional non-serious event of "nodules.".

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Type of Device: 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10881785
• MDR Text Key: 217672483
• Report Number: 3005113652-2020-00718
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Catalogue Number: 95661
• Device Lot Number: V17LA80823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR