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

Model Number	95834
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Health professional reported in the article ¿a retrospective review of the safety and efficacy of low-dose triamcinolone mixed with hyaluronic acid fillers to reduce post-injection infraorbital swelling¿ that 19 patients were injected with juvéderm volbella® xc and seven patients with juvéderm® vollure¿ xc experienced swelling.One patient injected with juvéderm volbella® xc experienced ¿granulomas¿ that resolved completely without further adverse events once they were injected with hyaluronidase.Biopsy was not provided.
Additional Manufacturer Narrative
The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Clarification to implant date: 447 patients who underwent 706 infraorbital hyaluronic acid filler treatments from (b)(6) 2013 to (b)(6) 2020 by a single injector.Article citation: siperstein, robyn.Et al."a retrospective review of the safety and efficacy of low-dose triamcinolone mixed with hyaluronic acid fillers to reduce post-injection infraorbital swelling." j clin aesthet dermatol.2022 apr;15(4):13-19.A request for further information have been made.Allergan has received no response from the authors.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
Additionally, in the article "a retrospective review of the safety and efficacy of low-dose triamcinolone mixed with hyaluronic acid fillers to reduce post-injection infraorbital swelling" also noted patient was injected into the tear troughs and mixing low-dose triamcinolone with juvéderm® (off-label usage).This is the same article reported under mdr id#: 3005113652-2022-00287 (allergan complaint#: (b)(4).This mdr is being submitted for the suspect product, juvéderm volbella® xc.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Event or Problem Description
Additionally, the healthcare professional reported injecting the patient under the eyes with 1 cc of juvéderm volbella® xc.The patient was pre-treated with blt (20%, 10%, 6%) and was given ice post-treatment.Adverse event occurred three months post-injection at the injection site.The patient was treated with hylenex.2 cc/5-fu 0.4/lidocaine with epi 0.1cc 6 days later, again 4 days later, again a month later, again half a month later, and once more 13 days later.The event resolved the following month.
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.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Health professional reported in the article ¿a retrospective review of the safety and efficacy of low-dose triamcinolone mixed with hyaluronic acid fillers to reduce post-injection infraorbital swelling¿ that 19 patients were injected with juvéderm volbella® xc and seven patients with juvéderm® vollure¿ xc experienced swelling.One patient injected with juvéderm volbella® xc experienced ¿granulomas¿ that resolved completely without further adverse events once they were injected with hyaluronidase.Biopsy was not provided.

• 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: 14279430
• Report Number: 3005113652-2022-00244
• Device Sequence Number: 6209565
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2022

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: 02/13/2019
• Device Model Number: 95834
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 05/18/2022; 09/15/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/16/2022; 05/23/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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: BLT (20%, 10%, 6%)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female