MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96637RX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/18/2020

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.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 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 juvéderm® voluma¿ with lidocaine in the nasogenian groove.Product was injected in a facial artery.Immediately after the injection, patient experienced "an occlusion of the artery, even reaching the lesion to the forehead." event caused "whitening and then the violet coloration of the path of the facial artery." the patient treated with hyaluronidase and hospitalized.The patient evolved positively and "is fine, fully recovered.".

Manufacturer Narrative

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

Event Description

Healthcare professional reports patient injection with juvéderm® voluma¿ with lidocaine in the nasogenian groove.Product was injected in a facial artery.Immediately after the injection, patient experienced "an occlusion of the artery, even reaching the lesion to the forehead." event caused "whitening and then the violet coloration of the path of the facial artery." the patient treated with hyaluronidase and hospitalized.The patient evolved positively and "is fine, fully recovered.".

Manufacturer Narrative

Additional data: b.5., d.6.

Event Description

Hyaluronidase was applied immediately after injection.Symptoms resolved 2 weeks later.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE
• 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: 10289255
• MDR Text Key: 199265285
• Report Number: 3005113652-2020-00398
• 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,Followup
• Report Date: 09/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 96637RX
• Device Lot Number: VB20A90733
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/28/2020; 08/27/2020
• Supplement Dates FDA Received: 08/24/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 51 YR