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	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting the patient in the lips with a half a syringe of juvéderm® volbella¿ xc.Two weeks later, the patient was injected with additional half syringe of juvéderm® volbella¿ xc in the lips.Eight weeks later, the patient experienced ¿swelling, tenderness, and bumps¿ to lips with ¿multiple firm nodules present and mild erythema and warmth." the patient was recommended 50 mg of benadryl x 2 days.Five days later, the patient returned with worsening ¿swelling¿ to top and bottom lip.The patient was treated with 80mg of kenalog and was prescribed a medrol dosepak and augmentin 500mg bid x 7 days.The next day, the patient was treated with 1 vial of hylenex.Only half the vial was injected due to a large amount of ¿swelling" and patient discomfort.A week later, the swelling had improved and most of the filler was dissolved in the lower lip, but some nodules remained in the upper lip.The patient received 2 vials of hylenex, majority to the upper lip.Patient returned to the clinic one week later and lips had returned to previous size with no erythema, warmth, or tenderness.At this visit, patient reported new onset "numbness" to the left top lip.Healthcare professional recommended additional vial of hylenex at this time.Patient wanted to wait a month before next round of hylenex.Patient returned one month later, one small bump present to right upper lip.Per patient, "numbness" had improved and she reported only slight "tingling" upon palpation.At this visit, small amount of hylenex injected to bump on right upper lip.Patient returned one month later, "nodules, tingling, and numbness" had completely resolved.This is the same event and the same patient reported under mdr id# 3005113652-2023-00936 (abbvie complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvéderm® volbella¿ xc.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.The event is a physiological complication and analysis of the device generally does not assist abbvie 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: 18366657
• Report Number: 3005113652-2023-00935
• Device Sequence Number: 20776189
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: 10/07/2023
• Device Catalogue Number: 96183
• Device Lot Number: V15LB10913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2021
• 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 Age: 31 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White