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

Catalog Number UNK VOLBELLA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 08/07/2020

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.This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional reported that a patient was injected with juvéderm® volbella¿ with lidocaine.The patient experienced an ¿ischemic event¿ in the glabellar region.No other information was provided.

Event Description

Health professional reported that a patient was injected with juvéderm® volbella¿ with lidocaine.The patient experienced an ¿ischemic event¿ in the glabellar region.No other information was provided.

• Brand Name: UNK VOLBELLA
• 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: 10485039
• MDR Text Key: 205365157
• Report Number: 3005113652-2020-00531
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention