MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLLURE

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

Patient Problem Necrosis (1971)

Event Date 08/15/2020

Event Type  Injury  

Manufacturer Narrative

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.Clarification: 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 a patient experienced ¿inflammatory response¿ 2 days after injection of juvéderm® vollure¿ in the cheek.Patient was treated with medrol and augmentin and 4 days later; patient was noted to be "doing better." a week later, it had ¿spread from left cheek to right cheek and noticed a spot on cheek/undereye." treatment was noted as ¿drained fluid and believes necrotic." patient has had aerobic and anaerobic culture both are negative.

• Brand Name: VOLLURE (VOLUME UNKNOWN)
• 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: 10905216
• MDR Text Key: 218727482
• Report Number: 3005113652-2020-00736
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLLURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention