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

Catalog Number UNK VOLIFT

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

Patient Problem Granuloma (1876)

Event Date 10/15/2020

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 (hcp) reports late occurrence of granulomas on all injection sites on patient injected with [unspecified] juvéderm® voluma¿ and [unspecified] juvéderm® volift¿ on marionette lines and nasolabial fold.Granulomas diagnosed by biopsy.Symptoms on going.This is the same event and the same patient reported under mdr id# 3005113652-2020-00694 (allergan complaint #(b)(4). this mdr is being submitted for the second suspect product, [unspecified] juvéderm® volift¿.

• Brand Name: VOLIFT (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: 10898211
• MDR Text Key: 218249412
• Report Number: 3005113652-2020-00695
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLIFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention