MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/02/2020

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 of 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

Healthcare professional reported a patient was injected with 1ml of juvéderm® ultra in the lips and perioral area.Patient experienced occlusion in the perioral area.This was the initial use of syringe.Treatment of hylenex and warm compress was given on same day.Symptoms ongoing.No other information provided.

Event Description

Healthcare professional provided additional details regarding the event.Patient's lip above the vermillion border turning white after a 0.2 ml that was injected from above the vermillion border down into the mucosa 0.1 ml in two retrograde linear threads.Healthcare professional immediately started to massage the area vigorously and then notice the top left lip itself losing color.A warm compress was placed and continued massage.Once a vascular occlusion was confirmed, hylenex was injected every hour followed by massage and heat."this continued for 5 hours until we felt the occlusion had cleared." the next day, patient came back and still had "a faint reticular pattern present but better." radioactive frequency was applied and instructed patient to use "warm compresses to the site every hour for 20 minutes." the next day, a prp was performed on the affected area.Two days later, patient had "red light therapy" to the face for 30 minutes two days in a row and event have resolved four days later.

Manufacturer Narrative

Additional, changed, and/or corrected data: a.2., b.5., section c.Suspect product, b.7, d.4, d.10, h.4, h.6.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.

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 1ml of juvéderm® ultra in the lips and perioral area.Patient experienced occlusion in the perioral area.This was the initial use of syringe.Treatment of hylenex and warm compress was given on same day.Symptoms ongoing.No other information provided.

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 10748472
• MDR Text Key: 213452894
• Report Number: 3005113652-2020-00641
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VITAMIN SUPPLEMENTS.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR