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	Edema (1820)
Date of Event	01/04/2019
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 of "swelling" 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 injecting a patient with 1cc of juvéderm® ultra plus in the lips; 13 days later, patient was injected with 1cc of juvéderm volbella® xc in the tear troughs.During the volbella® xc injection, the patient was concomitantly injected with juvéderm voluma® xc in the cheeks, but no issues have been reported relating to the cheek injection.About 2 months later, the patient experienced swelling in both tear troughs.Patient also experienced angioedema and swelling in the lips that would initially present in the morning, then subside during the day.Two weeks later, the patient was treated with an antihistamine and possibly vitrase.Healthcare professional indicated the symptoms related to juvéderm volbella® xc resolved.Eight days later, the patient¿s lips became ¿lumpy/bumpy.¿ patient was treated with vitrase in the lips and received oral prednisone, xyzal, and benadryl as treatment.It was noted that the hardening of the lips was resolving.The next day the patient claimed they suffered from difficulty breathing.Symptoms are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2019-00200 (allergan complaint # (b)(4)).This is the first mdr submitted for the second suspect product, juvéderm volbella® xc.
Additional Manufacturer Narrative
Additional data:.
Event or Problem Description
Symptoms resolved about a month after treatment.

• 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: 8358946
• Report Number: 3005113652-2019-00176
• Device Sequence Number: 16194486
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 04/26/2019

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
• Initial Date Received by Manufacturer: 01/27/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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 VOLUMA® XC; JUVÉDERM VOLUMA® XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR