MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95834
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Erythema (1840)
Date of Event	01/25/2019
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.These events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been completed.No deviations or non-conformances noted.These are known potential adverse events addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting the patient in the glabella with 1 syringe of juvéderm volbella® xc.Three months later, the patient was injected in the marionette lines with 1 syringe of juvéderm volbella® xc.Two and a half months later, the patient presented with ¿swelling and erythema¿ at the injection site.The patient was treated the same day with prednisone, biaxin 500 mg bid x 30 days, and hylenex.This is the same event and the same patient reported under mdr id 3005113652-2019-00284 (allergan pr (b)(4)).This mdr is being submitted for the second injection of suspected product, juvéderm volbella® xc v15la70557.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: 8517822
• Report Number: 3005113652-2019-00290
• Device Sequence Number: 1465511
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P110033
• 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): 04/16/2019

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: 08/21/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: 67 YR