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	Visual Disturbances (2140)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported a patient was injected in each cheek with 0.5 juvéderm voluma® xc, in their upper lip with 1 syringe of juvéderm volbella® xc and on their crows feet and bunny lines with botox.The same day when the patient opened their eyes, they stated they saw a purple jagged line under each eye.The patient was treated with hyaluronidase and nitro paste.Hcp stated "if you look at the patient there are no signs of adverse events other than the color, they are seeing but when we took the patient to a different room the color, they saw changed to the color of the room they were in.¿ the patient was sent to a retina specialist but have not been contacted with examination results.Event status is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00849 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm volbella® xc.
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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe has been 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.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional (hcp) reported a patient was injected in each cheek with 0.5 juvéderm voluma® xc, in their upper lip with 1 syringe of juvéderm volbella® xc and on their crows feet and bunny lines with botox.The same day when the patient opened their eyes, they stated they saw a purple jagged line under each eye.The patient was treated with hyaluronidase and nitro paste.Hcp stated "if you look at the patient there are no signs of adverse events other than the color, they are seeing but when we took the patient to a different room the color, they saw changed to the color of the room they were in.¿ the patient was sent to a retina specialist but have not been contacted with examination results.Event status is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00849 (allergan 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: 16014819
• Report Number: 3005113652-2022-00850
• Device Sequence Number: 7341152
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/01/2023

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): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VOLUMA® XC AND BOTOX®
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female