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

Catalog Number 94151ED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

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 (hcp) reported that a patient was injected with 1ml of juvéderm® voluma® with lidocaine to the lateral cheek and with 2ml of juvéderm® volite¿ to acne scaring on upper cheeks.Patient immediately experienced blanching to the left orbital rim.Patient received led while hcp observed the patient.Hcp noted a slow capillary refill.Hcp hylased the area with 100iu and capillary refill was restored.

Manufacturer Narrative

Clarification to h6: the syringe has been discarded.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional (hcp) reported that a patient was injected with 1ml of juvéderm® voluma® with lidocaine to the lateral cheek and with 2ml of juvéderm® volite¿ to acne scaring on upper cheeks.Patient immediately experienced blanching to the left orbital rim.Patient received led while hcp observed the patient.Hcp noted a slow capillary refill.Hcp hylased the area with 100iu and capillary refill was restored.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13079892
• MDR Text Key: 282735248
• Report Number: 3005113652-2021-03482
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 94151ED
• Device Lot Number: VB20B10158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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
• Treatment: JUVÉDERM® VOLITE¿
• Patient Outcome(s): Required Intervention; Other