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

Catalog Number	96183
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
Via regulatory agency, patient reported "the nurse that injected the filler all hit the infraorbital nerve which caused severe pain.My face is still numb and burning after post 1.5 years.I am told the nerve is permanently damaged." the injection site was reported as "puffy, with pea-sized areas" and "lumpy." the patient had 5-6 sessions to dissolve the filler, but reports that their face is still "numb and burning" 1.5 years post-injection and the nerve is "permanently damaged." additionally, the healthcare professional reported injecting the patient in the tear troughs with 0.55 ml of juvéderm® volbella¿ xc and with 1 ml of juvéderm® vollure¿ xc.The events occurred at the injection site.The patient was treated with hylenex 3 months later, again 16 days, again 8 days later, again 1.5 weeks later, and again 2 months later, totaling 10 ml.Five months later, a soft tissue ultrasound was performed that resulted in ¿no evidence of residual filler, no evidence of soft tissue granuloma, no visible infraorbital neural swelling, no perineural soft tissue abnormality, unremarkable ultrasound appearance of right infraorbital nerve and artery.¿ the patient had radiofrequency microneedling thought the same year, over 2 months apart.Event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00866 (allergan complaint #(b)(4) and mdr report # mw5113745.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: 16039687
• Report Number: 3005113652-2022-00865
• Device Sequence Number: 12316844
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2022
• Device Catalogue Number: 96183
• Device Lot Number: V15LB00640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• 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: Other; Required Intervention
• Patient Sex: Female