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 Cytomegalovirus (CMV) Infection (2220)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: botox®.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that a patient was injected in the lips and perioral lines with 1 ml of juvéderm® volift® with lidocaine.The patient was concomitantly injected in the glabella with botox®.The patient had ¿minimal bruising and pin-point bleeding¿ that was controlled at the injecting clinic.The patient was sent home with an ice pack and after care instructions.The patient later developed ¿swelling and tenderness¿ in the lips, ¿nodules¿ under the oral commissures, and ¿ulcers inside the mouth due to swelling and them rubbing against [the] teeth." the health professional recommended the patient take oral antis, take antihistamines and antiviral and return for a review in one week to determine is hyalase is needed or not.The event is ongoing.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 11802550
• MDR Text Key: 249992070
• Report Number: 3005113652-2021-00261
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 94703ED
• Device Lot Number: V17LA90818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR