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 Vascular System (Circulation), Impaired (2572)

Event Date 06/13/2020

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

Patient reported they were injected with juvéderm vollure¿ xc in the cheeks, marionette lines and nasolabial folds, and juvéderm® ultra.On the day of injection, patient experienced ¿vascular occlusion, bruising in left eye, lumps and can't feel the left side of mouth¿.Treatment is noted as hyaluronidase, nitroglycerin, nitrous oxide, cipro, prednisone, tramadol, and asa.Symptoms have resolved, but possible scarring was noted.This is the same event and the same patient reported under mdr id # 3005113652-2020-00426 (b)(4).This mdr is being submitted for juvéderm vollure¿ xc.

• 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: 10320430
• MDR Text Key: 200242166
• Report Number: 3005113652-2020-00425
• 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: consumer,health professional
• Type of Report: Initial
• Report Date: 07/24/2020

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 Catalogue Number: UNK VOLLURE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/24/2020
• 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: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® ULTRA, NOVOLOG INSULIN, AND BASAGLA
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR