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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Peeling (1999); Vascular System (Circulation), Impaired (2572)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported to have had injected a patient in the lips with 1 ml of juvéderm ultra plus¿ xc.Numbing cream was used as pre-treatment.On the following day, the patient called the injector to report ¿bruising outside of lip area and that lips were painful.¿ there was vascular occlusion in the lip and chin.The patient attended to the facility for a review and the doctor advised to hylase®.Hylase® was used on the same day, the day after, and once more the day after that.The patient is "still a little red on [the] chin where [the patient] scabbed but that has healed".The patient was seen for a review about 2 weeks later and "it had resolved".

• 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 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 9179329
• MDR Text Key: 173190739
• Report Number: 3005113652-2019-00703
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 94155ED
• Device Lot Number: H30LA80619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR