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

Catalog Number 94728JR

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

Patient Problem Cytomegalovirus (CMV) Infection (2220)

Event Date 05/15/2021

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 event of herpes simplex is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 (hcp) reported that patient was injected in the marionettes with 1ml juvéderm® volbella¿ with lidocaine.One week later, patient was injected in the lips with 1ml juvéderm® volbella¿ with lidocaine and 0.3 ml juvéderm® ultra smile.Approximately six months later, patient received first dose of moderna covid-19 vaccine.One day later, patient developed inflammation and hardening in the right lower lip.Patient was prescribed tapering dose of prednisone 30mg for six days with no improvement.Patient was then prescribed zamene® 30mg for 2 weeks and bilaxten® for one week and symptoms worsened and spread beyond the injection sites.Patient visited hospital and was treated with urbason®.Approximately one month after symptoms developed, hcp examined and the area was still very inflamed and looked like herpes.Patient prescribed acyclovir.Symptoms ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-03046 (allergan complaint # (b)(4)). this mdr is being submitted for the first injection of the suspect product, juvéderm® volbella¿ with lidocaine.

Event Description

Healthcare professional (hcp) reported that patient was injected in the marionettes with 1ml juvéderm® volbella¿ with lidocaine.One week later, patient was injected in the lips with 1ml juvéderm® volbella¿ with lidocaine and 0.3 ml juvéderm® ultra smile.Approximately six months later, patient received first dose of moderna covid-19 vaccine.One day later, patient developed inflammation and hardening in the right lower lip.Patient was prescribed tapering dose of prednisone 30mg for six days with no improvement.Patient was then prescribed zamene® 30mg for 2 weeks and bilaxten® for one week and symptoms worsened and spread beyond the injection sites.Patient visited hospital and was treated with urbason®.Approximately one month after symptoms developed, hcp examined and the area was still very inflamed and looked like herpes.Patient prescribed acyclovir.Symptoms ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-03046 (allergan complaint # (b)(4). this mdr is being submitted for the first injection of the suspect product, juvéderm® volbella¿ with lidocaine.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: g.1., h.6.

Event Description

Additionally, the health professional reported that the events have resolved.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• MDR Report Key: 12131813
• MDR Text Key: 266172083
• Report Number: 3005113652-2021-03045
• 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
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA90261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention