MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96181

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Visual Impairment (2138); Foreign Body Embolism (4439)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The events of vascular occlusion and vision abnormalities are 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 discarded.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

Health professional reported injecting a patient in the lateral half of the tear troughs with 0.3 cc of juvéderm volbella® xc on each side.That day, the patient experienced ¿vascular occlusion and some mottling to the right cheek¿ with ¿double vision¿ the next day.The patient was treated the same day with hylenex.The event is ongoing.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data.

Event Description

Health professional reported injecting a patient in the lateral half of the tear troughs with 0.3 cc of juvéderm volbella® xc on each side.That day, the patient experienced ¿vascular occlusion and some mottling to the right cheek¿ with ¿double vision¿ the next day.The patient was treated the same day with hylenex.The event is ongoing.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• MDR Report Key: 11609223
• MDR Text Key: 243603923
• Report Number: 3005113652-2021-00199
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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: 06/16/2022
• Device Catalogue Number: 96181
• Device Lot Number: V15LB00522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNTHROID, MULTIVITAMINS.; SYNTHROID, MULTIVITAMINS
• Patient Outcome(s): Other; Required Intervention