MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLIFT WITH LIDOCAINE 2 X 1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95517II

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

Patient Problem Foreign Body Reaction (1868)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

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.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 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 Description

Healthcare professional reports patient injection with 1 ml juvéderm® volift® xc, 3 ml juvéderm® voluma® xc and 1 ml juvéderm® volite® in the midface, marionette lines, and corner of lips.6 months later, patient experienced swelling and lumps of the infra orbital, malar, zygomatic and perioral areas.Oral antibiotics and chymoral forte provided.Treatment changed to augmentin, a low dose steroid and anti-inflammatories post communication with allergan medical professionals.The following week, blood tests completed.After examination 2 weeks post symptom apparition, it was noticed that edema had settled over the malar and zygomatic region.Perioral and infraorbital regions were very firm upon palpation (felt like marbles).Per physician, firmness upon palpation "doesn't feel like a normal filler." sonography, smear for bacteria, tuberculosis and atypical smears and biopsy completed.Patient advised to continue antibiotics.Patient refused to complete a covid test.Biopsy showed most likely a foreign body granuloma to the filler.The smears for bacteria, tuberculosis and atypical smears were negative.One month post symptom apparition, allergan medical professional suggested that the antibiotics be stopped.3 days later, a guided ultrasound was performed to dissolve filler with hyaluronidase as the material was rather firm to inject and the position of the filler to dissolve would be precise.Low dose steroid for 3-5 days post hyaluronidase treatment was advised.Symptoms ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-005323(allergan complaint #(b)(4)).This mdr is being submitted for the juvéderm® volift® xc.

Event Description

Additional information provided that "multiple points of usg guided hyalase was done for the patient as biopsy showed a foreign body granuloma, and the problem is resolved now.".

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: JUVEDERM VOLIFT WITH LIDOCAINE 2 X 1 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
• MDR Report Key: 10524773
• MDR Text Key: 206778366
• Report Number: 3005113652-2020-00532
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 95517II
• Device Lot Number: V17LA90228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE, JUVEDERM VOLITE
• Patient Outcome(s): Required Intervention