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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient experienced a "really bad reaction" clarified as "granulation tissue formation in the lips as well as a spot by nose and chin 1 cm round" after they were injected with one syringe of juvéderm® volbella¿ xc.Treatment is noted as 1ml of hyaluronidase.Biopsy was not provided.Event is ongoing at this time.
Additional Manufacturer Narrative
Adverse event problem, type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation and discarded.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 reported a patient experienced a "really bad reaction" clarified as "granulation tissue formation in the lips as well as a spot by nose and chin 1 cm round" after they were injected with one syringe of juvéderm® volbella¿ xc.Treatment is noted as 1ml of hyaluronidase.Biopsy was not provided.Event is ongoing at this time.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a4.
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.
Event or Problem Description
Healthcare professional reported a patient experienced a "really bad reaction" clarified as "granulation tissue formation in the lips as well as a spot by nose and chin 1 cm round" after they were injected with one syringe of juvéderm® volbella¿ xc.Treatment is noted as 1ml of hyaluronidase.Biopsy was not provided.Event is ongoing at this time.

• 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: 16618896
• Report Number: 3005113652-2023-00231
• Device Sequence Number: 20332628
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2023

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: 09/11/2023
• Device Catalogue Number: 96183
• Device Lot Number: V15LB10802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 04/14/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/03/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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 Sex: Female
• Patient Weight: 73 KG