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	08/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Via regulatory agency (mw5111796), healthcare professional reported injecting a patient in the upper lip with 0.55 ml of juvéderm® volbella¿ xc in the nasolabial folds with 1 ml of juvéderm® vollure¿ xc.Five months later, patient experienced severe swelling of the injection sites that was minimally tender and two visible erythematous nodules on the upper cutaneous lip.The event was described as "linear induration erythematous." the patient was treated with doxycycline and medrol dosepak 4 days later.Twelve days later, the patient was treated with prednisone ¿in a tapering fashion¿ and clarithromycin bid x 10 days.The patient had the covid-19 vaccine 4 weeks pre-onset.Symptoms are relapsing when steroid dosage is decreased.Patient is still on steroids orally to control the inflammation.Inflammation does not seem to be infectious.Antibodies have not been helpful as symptoms relapse when the prednisone dosage decreased below 40 mg/day, despite 20 days of antibiotic use.Symptom ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00637 (allergan complaint (b)(4)).This mdr is being submitted for the suspect product, juvéderm® volbella¿ xc.
Additional Manufacturer Narrative
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.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.

• 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: 15567402
• Report Number: 3005113652-2022-00636
• Device Sequence Number: 20323308
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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: 02/08/2023
• Device Catalogue Number: 96183
• Device Lot Number: V15LB10218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JUVÉDERM® VOLLURE¿ XC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female