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	08/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification to section c.Suspect product: lot number 963/3.Continued h.6.Type of investigation code: b15, b17, b20.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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Hcp reported injecting a patient in the lips with one syringe of juvéderm volbella® xc.18 days later, patient was injected in the lips with an additional syringe of juvéderm volbella® xc.54 days later, patient started experiencing swelling in the lips, bruising in the lips, warm lips, and bumps on lips.The swelling in the lips, the lips were warm, and bumps were all related as they are inflammatory nodules.Eight days later, patient was provided benadryl, kenalog shot, and antibiotics as treatment.Event resolved about a month and a half later.This is the same event and the same patient reported under mdr id# 3005113652-2023-00931 (abbvie complaint #(b)(4)).This mdr is being submitted for the second 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: 18336434
• Report Number: 3005113652-2023-00932
• Device Sequence Number: 20936347
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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: 08/02/2024
• Device Catalogue Number: 96183
• Device Lot Number: 1000541101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: 31 YR
• Patient Sex: Female