MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155ED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The filler was injected into the patient and is not accessible for return.The syringe has been discarded.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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.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 (hcp) reported patient was infected in the chin with juvéderm® voluma® with lidocaine and juvéderm® ultra plus xc.Patient experienced an occlusion the next day, which patient reported to hcp two days later.Hcp then treated with red light, hirudoid® bruise cream, and hyaluronidase ¿full lower chin and surrounds flood.Cap refill was less 2 to whitened area on apex of chin, pain and reticulated rash noted on review.¿ there was no permanent damage.The event resolved 4 days later.This is the same event and the same patient reported under mdr id# 3005113652-2022-00428 (allergan complaint #pr (b)(4).This mdr is being submitted for the suspect product, juvéderm® ultra plus xc.

• Brand Name: JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC)
• 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: 15275446
• MDR Text Key: 298394936
• Report Number: 3005113652-2022-00522
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 94155ED
• Device Lot Number: H30LB10555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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® WITH LIDOCAINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female