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 Problems Headache (1880); Anxiety (2328); Depression (2361)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional (hcp) reported concomitantly injecting a patient with 1 syringe of juvéderm® ultra plus xc, 1 syringe of juvéderm vollure¿ xc, and 18 units of botox®.3 days later, the patient reported experiencing ¿anxiety, headache, labile emotional state and depression.¿ the patient went to the emergency room and was treated with unspecified anxiety medications and discharged.The hcp added that ¿the patient doesn¿t want to get dependent on the medications¿.The patient reported being ¿okay when working¿, but ¿as soon as the patient leaves to get in the car, the patient gets emotional and wants the fillers out.¿ the patient has no history of anxiety or depression.The symptoms have not resolved.This is the same event and the same patient reported under mdr id # 3005113652-2019-00529 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm vollure¿ xc.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8782051
• MDR Text Key: 150752299
• Report Number: 3005113652-2019-00530
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: 95661
• Device Lot Number: V17LA80611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2018
• 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
• Treatment: JUVÉDERM® ULTRA PLUS XC, BOTOX®
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR