MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96656JR

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

Patient Problems Burn(s) (1757); Viral Infection (2248)

Event Date 02/15/2022

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 are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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 events of "viral infection" and "sunburn," deemed not related to the device are considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported injecting a patient in the lips with 0.4 ml of juvéderm® volift® retouch.Ten months later, the patient was injected in the tear trough with 0.3 ml of juvéderm® volift® with lidocaine and botox®.Four months later when patient returned from a trip and reported ¿bilateral palpebral edema¿ in the dark circles and then lips after a sunburn and or a viral infection, deemed not related to the device.It persisted for one month.On examination, it was a little indurated so the patient was treated with solupred 20mg for 7 days then decreased.The patient received additional botox® a month after returning from their trip.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00219 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volift® with lidocaine.

Event Description

Additionally, the healthcare professional reported currently decreasing corticosteroids and that the event resolved 2 months post-onset.

• Brand Name: JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14115751
• MDR Text Key: 289536363
• Report Number: 3005113652-2022-00222
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 08435219540078
• UDI-Public: 8435219540078
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 96656JR
• Device Lot Number: V17LB10390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: BOTOX®
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female