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

Catalog Number 94154ED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "occlusion" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional reported injecting a patient in the lip with juvéderm ultra® xc.The patient experienced ¿corner of the mouth left side upper and lower occlusion.¿ patient was treated with arnica cream after injection.The lip was massaged.The next day, patient received hyalase, and again the day after."the color of the lips returned".Physician planned to "apply the clinic led light every 24 hours".Symptoms resolved 4 days after onset.

• 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 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10224263
• MDR Text Key: 197319569
• Report Number: 3005113652-2020-00351
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LA90529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUMBING TOPICAL
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR