MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (2 X 0.4 ML); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 93899

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

Patient Problems Erythema (1840); Vascular System (Circulation), Impaired (2572)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events of redness and vascular event are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.This is a known potential adverse event addressed in the product labeling.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.

Event Description

Healthcare professional reported after injection in the "glabella and pre jowl focus" with one syringe juvéderm® ultra xc, the patient experienced ¿redness that was found to be a vascular event¿ noticed two days after injection.6 days after injection, the patient was injected with hylenex as treatment; 3 days later, nitrobid paste was given as treatment.Symptoms are ongoing.

• Brand Name: JUVEDERM ULTRA XC (2 X 0.4 ML)
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8202293
• MDR Text Key: 131585038
• Report Number: 3005113652-2018-01815
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: 30888628000074
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2019
• Device Catalogue Number: 93899
• Device Lot Number: H24LA80171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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
• Patient Age: 56 YR