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 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 that during an injection of 1 syringe juvéderm® ultra xc in the lips, there was "blanching at first, but then it went away." "then later that evening, patient had numbness, pain, bruising and a vascular occlusion." it was noted that the next day, the hcp "injected hyaluronidase in the bottom lip.¿ the symptoms have resolved.

Manufacturer Narrative

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

Event Description

Healthcare professional reported that during an injection of 1 syringe juvéderm® ultra xc in the lips, there was "blanching at first, but then it went away." "then later that evening, patient had numbness, pain, bruising and a vascular occlusion." it was noted that the next day, the hcp "injected hyaluronidase in the bottom lip.¿ the symptoms have resolved.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10781777
• MDR Text Key: 214519699
• Report Number: 3005113652-2020-00684
• 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: health professional
• Reporter Occupation: Nurse Practitioner
• 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: 11/03/2020
• 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: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR