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 09/02/2020

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 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

Health professional reported injecting a patient in the lips with one syringe of juvéderm® ultra xc and in the chin with one syringe of juvéderm voluma® xc.The patient experienced ¿vascular occlusion¿ in the lips that same day.The patient was treated with 300 cc of hylenex and again with another 825 cc.The patient was treated with hot towels and massaged as well.The event was reported as ¿cleared up.¿.

Manufacturer Narrative

Additional, changed, and/or corrected data: d.4., h.6.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Health professional reported injecting a patient in the lips with one syringe of juvéderm® ultra xc and in the chin with one syringe of juvéderm voluma® xc.The patient experienced ¿vascular occlusion¿ in the lips that same day.The patient was treated with 300 cc of hylenex and again with another 825 cc.The patient was treated with hot towels and massaged as well.The event was reported as ¿cleared up.¿.

• 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: 10643276
• MDR Text Key: 210372307
• Report Number: 3005113652-2020-00580
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM VOLUMA® XC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR