MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA XC/LIDO

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/30/2022

Event Type  Injury  

Event Description

Healthcare professional reported that patient was injected with juvéderm® ultra in lip perioral area and a vascular occlusion occurred.

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 not returned for evaluation.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14047908
• MDR Text Key: 288878145
• Report Number: 3005113652-2022-00216
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA XC/LIDO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other