MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155EC

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event 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 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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a patient was injected with 1.0 ml of juvederm ultra plus xc in the lips.Patient experienced "an occlusion that occurred" and "irregular vascularity to upper lip" on same day of injection.Patient was treated with hyaluronidase the next day and the day afterward.Event has been resolved.

Manufacturer Narrative

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

Event Description

Healthcare professional reported a patient was injected with 1.0 ml of juvederm ultra plus xc in the lips.Patient experienced "an occlusion that occurred" and "irregular vascularity to upper lip" on same day of injection.Patient was treated with hyaluronidase the next day and the day afterward.Event has been resolved.

• Brand Name: JUVEDERM ULTRA PLUS XC 1 ML ROW
• 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: 10857182
• MDR Text Key: 216840169
• Report Number: 3005113652-2020-00706
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Catalogue Number: 94155EC
• Device Lot Number: H30LA90268
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR