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

Catalog Number 94703ED

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

Patient Problems Edema (1820); Rash (2033)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

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 facial swelling and rash are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.This is a known potential adverse event addressed in the product labeling.A device history record review has been initiated and analysis of the data has not been completed.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the cheeks and 2 months later had another injection with juvéderm volift with lidocaine in the lips.About 10 months after later, the patient woke up with facial swelling.Patient had a sore throat and rash the same day.It was the injector's opinion that the patient had a response to something else.Patient had a cough or some kind of illness that was attributed as some kind of immune response.Patient was treated with prednisone and symptoms resolved.This is the same event and the same patient reported under mdr id #3005113652-2018-01818 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm volift with lidocaine, also a device manufactured by allergan.

• Brand Name: VOLIFT WITH LIDOCAINE
• 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: 8218406
• MDR Text Key: 132140052
• Report Number: 3005113652-2018-01819
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2019

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 94703ED
• Device Lot Number: V17LA70079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR