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 Problem Obstruction/Occlusion (2422)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "vascular occlusion" 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 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

Healthcare professional reported injecting a patient with juvéderm® volbella¿ xc.During injection, the patient experienced ¿a vascular occlusion¿ in the upper vermillion border of the lip.The patient was treated with hylenex, aspirin, prednisone 40 mg gel x 3, cephalexin 500 mg bid x 1 week, and ¿heat and massage¿hour.¿ the event is ongoing, noted: ¿slight discoloration/bruising remains.¿.

Manufacturer Narrative

Additional, corrected, and/or changed data: b.5., h.4., h.6.

Event Description

Additional information provided event have resolved approximately a month after treatment.

• 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
• 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: 14566059
• MDR Text Key: 293090278
• Report Number: 3005113652-2022-00308
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: 10888628043541
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 35 YR
• Patient Sex: Female