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

Catalog Number 96637RX

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 04/07/2022

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 events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that a patient was injected with juvéderm voluma® xc.Patient later experienced ¿nasal ischemia¿.Symptom status is unknown.

Manufacturer Narrative

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.

Event Description

Additionally, the healthcare professional reported injecting the patient in the nose with 0.3 cc of juvéderm voluma® xc and developed "hematoma and white vesicles¿ in the nasal undertip 48 hours after injection.The patient was treated with hyaluronidase 90v and aspirin [illegible] 72hrs 200 un to avoid ¿nasal dermal necrosis.¿ the event resolved but noted as ¿in progress.¿.

Event Description

Healthcare professional reported that a patient was injected with juvéderm voluma® xc.Patient later experienced ¿nasal ischemia¿.Symptom status is unknown.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE
• 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: 14149123
• MDR Text Key: 290095391
• Report Number: 3005113652-2022-00229
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07795316000273
• UDI-Public: 7795316000273
• Combination Product (y/n): Y
• Reporter Country Code: AR
• 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,Followup
• Report Date: 05/19/2022

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: 05/31/2023
• Device Catalogue Number: 96637RX
• Device Lot Number: VB20B10442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/21/2022; 04/28/2022
• Supplement Dates FDA Received: 04/28/2022; 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 75 KG