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

Catalog Number 96637JR

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

Patient Problems Facial Nerve Paralysis (1846); Inflammation (1932); Skin Irritation (2076)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: date of injections provided as (b)(6) 2020 and (b)(6) 2020.It is unknown which product was injected on which date.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.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.Clarification: "inflammatory nodules" is a known potential adverse event addressed in the product labeling."paralysis in the mouth" is considered an unexpected adverse drug experience.

Event Description

Health professional (hcp) initially reported patient experienced "paralysis in the mouth¿ with unspecified juvéderm® voluma¿.Later, hcp further specified that patient also experienced inflammatory nodules after the injection of 3 ml of juvéderm® voluma¿ with lidocaine in the cheek, 1 ml of juvéderm® volbella¿ with lidocaine in the periorbital area, juvéderm® volux¿ in the chin and jaw area, and in the with juvéderm® volift¿ with lidocaine in the perioral area during two injections 4 months apart.The patient was treated that day with solupred 60 mg/10 days, ice, and augmentin 1grx/8 days.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00679 (allergan complaint # (b)(4) ), mdr id# 3005113652-2020-00680 (allergan complaint # (b)(4)), and mdr id# 3005113652-2020-00681 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm® voluma¿ with lidocaine.

Manufacturer Narrative

Additional, changed, and/or corrected data: h.6.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Health professional (hcp) initially reported patient experienced "paralysis in the mouth¿ with unspecified juvéderm® voluma¿.Later, hcp further specified that patient also experienced inflammatory nodules after the injection of 3 ml of juvéderm® voluma¿ with lidocaine in the cheek, 1 ml of juvéderm® volbella¿ with lidocaine in the periorbital area, juvéderm® volux¿ in the chin and jaw area, and in the with juvéderm® volift¿ with lidocaine in the perioral area during two injections 4 months apart.The patient was treated that day with solupred 60 mg/10 days, ice, and augmentin 1grx/8 days.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00679 (allergan complaint # 2280259), mdr id# 3005113652-2020-00680 (allergan complaint # 2280260), and mdr id# 3005113652-2020-00681 (allergan complaint # 2280261).This is the first mdr submitted for the first suspect product, juvéderm® voluma¿ with lidocaine.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Additionally, the health professional reported that the juvéderm® voluma¿ was injected two months prior to event occurred.

Event Description

Additionally, the health professional reported that the juvéderm® voluma¿ was injected two months prior to event occurred.

• Brand Name: JUVEDERM VOLUMA 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
• MDR Report Key: 10756656
• MDR Text Key: 213714182
• Report Number: 3005113652-2020-00635
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2021

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: 11/30/2021
• Device Catalogue Number: 96637JR
• Device Lot Number: VB20A90790
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 01/07/2021; 02/12/2021
• Supplement Dates FDA Received: 11/18/2020; 02/05/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR