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	Inflammation (1932); Skin Irritation (2076)
Date of Event	02/15/2019
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.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported ¿inflammatory nodule, some visible¿ on their lower right jaw, above/upper lips and marionette region, 6 months after injection with one syringe of juvéderm volbella® xc.Treatment is noted as ciprofloxacin, doxycycline, prednisone, and hylenex.Two weeks after filler patient had a heart attack.Patient had shingles, a sinus and ear infection four months after injection, lasting for 3 months; these were determined to not be device related.Events are ongoing at this time.Patient was concomitantly injected with 2 syringes of juvéderm vollure¿ xc.This is the same event and the same patient reported under mdr id # 3005113652-2019-00535 (allergan (b)(4)).This mdr is being submitted for juvéderm volbella® xc.

• 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: 8782575
• Report Number: 3005113652-2019-00532
• Device Sequence Number: 2665897
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: MO
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 01/04/2020
• Device Catalogue Number: 95834
• Device Lot Number: V15LA80151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• 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: 57 YR