MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA/24HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The filler was injected into the patient and is not accessible for return.The syringe has been discarded.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional injecting a patient in the chin with 0.8 cc of juvéderm® voluma¿ xc and in the lip with 0.7 cc of juvéderm® ultra.The patient experienced a ¿possible occlusion¿ at the injection site the next day.Patient was treated with 6 vials of hylenex, 3 in the chin and 3 in the lips.The next day, the patient was treated with 2 vials of hylenex, 1 in the chin and 1 in the lips.The event resolved that day with no permanent damaged.This is the same event and the same patient reported under mdr id# 3005113652-2023-00165 (allergan complaint #(b)(4).This mdr is being submitted for the suspect product, juvéderm® ultra.

• Brand Name: JUVEDERM ULTRA/24HV (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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16479378
• MDR Text Key: 310623851
• Report Number: 3005113652-2023-00166
• 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
• Type of Report: Initial
• Report Date: 03/03/2023

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 Catalogue Number: UNK JUVEDERM ULTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA¿ XC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Race: Asian