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); Skin Irritation (2076)
Date of Event	04/11/2019
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 events are physiological complications 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 med watch will be submitted.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported 3 days after injection with 0.55 cc juvéderm volbella® xc into the lips, the patient developed ¿upper lip developed swelling¿ and ¿significant swelling, edema, multiple small nodules along sites of injection.¿ nine days after symptoms began the patient was treated with hyaluronidase, and 9 days later with hyaluronidase & loratadine.Symptoms are ongoing.

• 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: 8708299
• Report Number: 3005113652-2019-00485
• Device Sequence Number: 16697366
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: V15LA70729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• 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: 38 YR