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	Pain (1994); Skin Irritation (2076)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The reported event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported to have injected a patient with 3 syringes of juvéderm® voluma® xc in the cheeks, 1 syringe of juvéderm® volbella® xc in the lips, and 1 syringe of juvéderm® vollure® xc in the nasolabial folds.Almost 5 months after injection, the patient began to experience bumps and nodules at the injection sites.The patient has been injected by another healthcare professional with vitrase® 150 mg 2 times, two weeks apart.Vitrase® was injected to the lip nodules that were uncomfortable and painful to eat as well as changing the patient¿s smile, to the marionettes, and to the chin area.The healthcare professional further noted that the vitrase® treatment into the nodules occurred ¿with difficulty¿.The patient was also treated with steroids x2.The symptoms have resolved.This is the same event and the same patient reported under mdr id # 3005113652-2019-00162 (allergan complaint # (b)(4)) and mdr id # 3005113652-2019-00164 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, 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: 8363413
• Report Number: 3005113652-2019-00163
• Device Sequence Number: 2105902
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/22/2019

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: 09/19/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/22/2019
• 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® VOLLURE® XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR