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 Code	Skin Irritation (2076)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant therapies: multivitamins.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 completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) reported patient was injected with 2 syringes of juvéderm® ultra xc in the marionettes and lips and 1 syringe of juvéderm volbella® xc in the lips.About 4 weeks, later, the patient came back to the office and was injected with another syringe of juvéderm volbella® xc above the lips.About 3 years later, patient contacted the hcp and reported they developed "some sort of growth" in their lip and it had to be surgically removed.Hcp confirmed this surgery happened outside of their clinic and did not have any other details.The patient indicated the surgeon stated the "growth" could have been due to the filler.This is the same event and the same patient reported under mdr id # 3005113652-2019-00780 (allergan complaint #2016226) and mdr id #3005113652-2019-00782 (allergan complaint #2016232).This mdr is being submitted for the first injection of 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: 9291087
• Report Number: 3005113652-2019-00781
• Device Sequence Number: 13996178
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 08/01/2018
• Device Catalogue Number: 95834
• Device Lot Number: V15LA60355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JUVÉDERM® ULTRA XC, BLOOD PRESSURE MEDS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR