MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

Clarification to h.6.Type of investigation code: 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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting the patient with juvéderm® voluma® xc into the pyriform fossa.Next day, patient experienced vascular occlusion with nerve compression/facial numbness.Symptoms are on-going.

Manufacturer Narrative

Additional, corrected, and/or changed data.

Event Description

Healthcare professional (hcp) later reported "no vascular occlusion to be reported with this event.This medical report is to document nerve compression by filler injected.No vo.".

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19122214
• MDR Text Key: 340339567
• Report Number: 3005113652-2024-00262
• Device Sequence Number: 1
• Product Code: LMH
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 94640
• Device Lot Number: 1000622482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Race: Asian