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

Catalog Number 94703ZQ

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.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.The event of "vascular occlusion" 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 (hcp) reported injecting the patient's alar grove, ¿nasolabial fold ¿ alar facial sulcus¿, with 0.2 cc of juvéderm® volift¿ with lidocaine.Patient was concomitantly injected in the temples and cheek with 2.6 cc of juvéderm¿ voluma¿ with lidocaine.¿filler into facial artery¿ occurred.Hcp further noted that this was ¿inadvertent entry of filler into facial artery¿.Patient experienced vascular occlusion.Hcp saw blanching and noticed a bluish color over the facial/angular artery territory after.Hcp reported the event as not related to both products.Event assessed as related to juvéderm® volift¿ with lidocaine.Hcp injected hyaluronidase in the whole area, pulse protocol, and the patient left the office four hours later with good capillary refill.The hcp saw the patient again on the following day and injected more hyaluronidase.The capillary refill was 2 sec when the patient left.Patient was also treated with warm compress.The treatment was necessary to prevent permanent damage.Symptoms resolved 8 days after the day of onset.

• Brand Name: VOLIFT WITH LIDOCAINE
• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10316912
• MDR Text Key: 200418473
• Report Number: 3005113652-2020-00391
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 94703ZQ
• Device Lot Number: V17LA80557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR