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

Catalog Number 94731RX

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/01/2020

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 event of "vascular occlusion" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 injecting a patient in multiple injection areas with juvéderm® volbella¿ with lidocaine.When treating the frontal region with 0.15ml, using a 22g canula, the physician noticed ¿frontal ischemia.¿ upon removal of the cannula there was a ¿blood reflex.¿ the physician immediately administered 800iu of hyaluronidase, at which time the physician noticed improvement in the local aspect and improvement in the perfusion of the area.The event is ongoing.

Event Description

Additionally, the health professional reported that the event resolved 15 days after onset.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5., b.7., c, d.4., d.11., h.4., h.6.Clarification to h6: the filler was injected into the patient and is not accessible for return.The syringe was discarded.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.

Event Description

Health professional reported injecting a patient in multiple injection areas with juvéderm® volbella¿ with lidocaine.When treating the frontal region with 0.15ml, using a 22g canula, the physician noticed ¿frontal ischemia.¿ upon removal of the cannula there was a ¿blood reflex.¿ the physician immediately administered 800iu of hyaluronidase, at which time the physician noticed improvement in the local aspect and improvement in the perfusion of the area.Additionally, the health professional reported that the event resolved 15 days after onset.

Manufacturer Narrative

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

• 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 74370 ; FR 74370
• MDR Report Key: 10610828
• MDR Text Key: 209342604
• Report Number: 3005113652-2020-00612
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA90154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR