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 Problem Facial Nerve Paralysis (1846)

Event Date 03/05/2019

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.

Event Description

Healthcare professional reported that the patient was injected in the lips and oral commissures with 1 ml of juvéderm® volift® with lidocaine.The patient was concomitantly injected with botox® reconstituted with 2.5ml ns in the frontals area, glabella, and crow's feet.3 days later, the patient noticed facial drooping.The injector further described the event as bell's palsy / facial paralysis.Bell's palsy was provided as definitive diagnosis.The patient contacted the clinic on the fallowing day.The patient was treated in hospital with antivirals and prednisolone the day after.About a month and a half later, the patient still has facial paralysis to left side of the face, which was improved.The patient is 95% recovered.

Manufacturer Narrative

Additional, corrected, and/or changed data:.

Event Description

Additionally, the healthcare professional reported that the injections could have triggered everything, but could also be a coincidence.The healthcare professional also reported that ¿likely trauma from the needle triggered the virus.¿.

• 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
• MDR Report Key: 8574140
• MDR Text Key: 143849502
• Report Number: 3005113652-2019-00374
• Device Sequence Number: 1
• Product Code: LMH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 94703ED
• Device Lot Number: V17LA80620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOTOX® RECONSTITUTED WITH NS; BOTOX® RECONSTITUTED WITH NS
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR