MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE

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

Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 11/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of blue coloration, red, heaviness, swelling and blisters are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.There are known potential adverse events addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient with unspecified juvéderm voluma to the midface (ck3) and unspecified juvéderm ultra plus in the tear trough.Patient complained of blue coloration of the skin and then left the side turned up red at the base of the nose on the same day.On the 2nd day, the patient felt heaviness on their left side of the face with swelling.Blisters also formed inside the mouth later on.Patient was treated with hylase.The issue was only related to unspecified juvéderm voluma as it was used on the effected side.Symptoms are ongoing.Patient concomitantly takes anti diabetic medication and thyronorm.

• Brand Name: JUVEDERM VOLUMA (VOLUME/ADDITIVE 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8239340
• MDR Text Key: 132779542
• Report Number: 3005113652-2018-01742
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/11/2019

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 JUVEDERM VOLUMA-ADDITIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/11/2019
• 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: UNSPECIFIED JUVÉDERM ULTRA PLUS, ANTI DIABETIC MED
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR