MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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

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

Event Type  Injury  

Manufacturer Narrative

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.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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional (hcp) reported that a patient was injected in the nasolabial folds with juvéderm vollure¿ xc.On the following day the patient presented to the facility with vascular complication and tenderness on the right side.The hcp has started treating with hylenex to the right side.Event is ongoing.

Event Description

Healthcare professional (hcp) reported that a patient was injected in the nasolabial folds with juvéderm vollure¿ xc.On the following day the patient presented to the facility with vascular complication and tenderness on the right side.The hcp has started treating with hylenex to the right side.Event is ongoing.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 10421299
• MDR Text Key: 203359932
• Report Number: 3005113652-2020-00444
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 95661
• Device Lot Number: V17LB00048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention