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

Catalog Number 94154ED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/21/2023

Event Type  Injury  

Event Description

Healthcare professional reported that patient was injected with 0.4ml juvéderm ultra® xc in lower lip.Patient developed a vascular occlusion during injection.Almost immediately, patient was treated with hyalase® 1500iu in 2ml n/s.One day later, patient's capillary fill was instant.Symptoms has been resolved.

Manufacturer Narrative

Suspect product: lot number 963/2.Health effect- impact code: f2303.Type of investigation code: b15, b18, b20.Invest.Conclusions code: d15.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe has been 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.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.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM ULTRA XC (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: 16499170
• MDR Text Key: 310833467
• Report Number: 3005113652-2023-00164
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Catalogue Number: 94154ED
• Device Lot Number: 1000500552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Female