MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	96183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued h.6.Type of investigation code: b15, b17, b20.A review of the device history record has been completed.No deviations or non-conformances noted.Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) reported a patient was injected in the lips with 1 syringe of juvéderm volbella® xc and in the cheeks with 2 syringes of juvéderm voluma® xc.Approximately six months post injections the patient experienced, granulomas.The hcp assessed the patient three weeks later their diagnosis was the following, ¿little bumps in lips and swelling some lumps in l cheek with swelling and granulomas¿.The next day after the assessment the patient was treated with oral prednisone/ doxycycline.Symptoms are ongoing.This is the same event and the same patient reported under mdr id#3005113652-2023-00575 (abbvie complaint (b)(4) ).This mdr is being submitted for the 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17406123
• Report Number: 3005113652-2023-00574
• Device Sequence Number: 12237261
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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: 10/06/2023
• Device Catalogue Number: 96183
• Device Lot Number: V15LB10890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female