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

Catalog Number	93899
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Vascular System (Circulation), Impaired (2572)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 8202293
• Report Number: 3005113652-2018-01815
• Device Sequence Number: 1710506
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: 30888628000074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2019
• Device Catalogue Number: 93899
• Device Lot Number: H24LA80171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR