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

Catalog Number 94151ED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a ¿vascular event¿ and "post injection assessment blanching spot r nasal alar no cap refill" whilst treatment was being injected in the nasolabial folds and "nasal alar" with juvéderm® voluma® with lidocaine.Treatment is noted as "1500iu hylase in 5ml [illegible] nacl, with 30g & bd insulin syringe".Patient was also treated with warm compress, and aspirin.Event has resolved.

Event Description

Healthcare professional reported a ¿vascular event¿ and "post injection assessment blanching spot r nasal alar no cap refill" whilst treatment was being injected in the nasolabial folds and "nasal alar" with juvéderm® voluma® with lidocaine.Treatment is noted as "1500iu hylase in 5ml [illegible] nacl, with 30g & bd insulin syringe".Patient was also treated with warm compress, and aspirin.Event has resolved.

Manufacturer Narrative

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

• 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 74370 ; FR 74370
• MDR Report Key: 9824465
• MDR Text Key: 190316742
• Report Number: 3005113652-2020-00114
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 94151ED
• Device Lot Number: VB20A90008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANEXAMIC ACID, CHLORHEXIDINE.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR