MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVÉDERM VISTA VOLBELLA XC 2X1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94728JA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.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 patient was injected in nasolabial folds with 0.8cc juvederm vista volbella xc bilaterally.One day later, an embolism was suspected on the left side and was treated with hyaluronidase.

Event Description

Healthcare professional reported patient was injected in nasolabial folds with 0.8cc juvederm vista volbella xc bilaterally.One day later, an embolism was suspected on the left side and was treated with hyaluronidase.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: h.6.

• Brand Name: JUVÉDERM VISTA VOLBELLA XC 2X1ML
• 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: 15700747
• MDR Text Key: 302712674
• Report Number: 3005113652-2022-00730
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 04987836034194
• UDI-Public: 4987836034194
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 94728JA
• Device Lot Number: V15LB10861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female