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 12/10/2021

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.Patient weight was provided as 50 - 55 kgs.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "vascular occlusion" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 (hcp) reported a patient was injected in the lips with juvéderm® ultra xc.During the injection, the patient experienced ¿an occlusion." the patient was immediately treated with 3 vials of hyalase® (reconstituted with 5mls lignocaine).The symptoms were resolved two days post injection.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13061766
• MDR Text Key: 285535727
• Report Number: 3005113652-2021-03471
• 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: 12/22/2021

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LB10112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 50 KG