MAUDE Adverse Event Report: 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	Inflammation (1932)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
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 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.
Event or Problem Description
Healthcare professional reported a patient was injected with 5 syringes of juvéderm® voluma¿ xc into the cheeks and temples.Patient returned the following day and was injected with botox.The healthcare professional noticed that patient had minimal swelling to the face, but "all within parameters 24 hours post filler injection." a little over two weeks later, patient returned with no concerns and was injected with 1ml of juvéderm® voluma¿ xc into the cheeks and 0.55mls of juvéderm® volbella¿ xc into the lips.About three weeks later, patient had swelling in the left cheek and was advised to take zyrtec.Swelling resolved.A week later, patient experienced right cheek swelling and a medrol dose pack was started.Two days later, the swelling was better but a "bump" below the left eye and upper lip was noted.Swelling returned 5 days later and another medrol dose pack was started.The swelling improved the following day but the bumps remained present.5 days later, patient was seen in practice with no swelling.Massage and direct pressure were applied to the bumps and they were much improved.Swelling returned two days later generalized in the cheeks.Prednisone 5mg was started for 30 days.Events ongoing.
Event or Problem Description
Healthcare professional reported a patient was injected with 5 syringes of juvéderm® voluma¿ xc into the cheeks and temples.Patient returned the following day and was injected with botox.The healthcare professional noticed that patient had minimal swelling to the face, but "all within parameters 24 hours post filler injection." a little over two weeks later, patient returned with no concerns and was injected with 1ml of juvéderm® voluma¿ xc into the cheeks and 0.55mls of juvéderm® volbella¿ xc into the lips.About three weeks later, patient had swelling in the left cheek and was advised to take zyrtec.Swelling resolved.A week later, patient experienced right cheek swelling and a medrol dose pack was started.Two days later, the swelling was better but a "bump" below the left eye and upper lip was noted.Swelling returned 5 days later and another medrol dose pack was started.The swelling improved the following day but the bumps remained present.5 days later, patient was seen in practice with no swelling.Massage and direct pressure were applied to the bumps and they were much improved.Swelling returned two days later generalized in the cheeks.Prednisone 5mg was started for 30 days.Events ongoing.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: h4, h6.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24056424
• Report Number: 3005113652-2026-00025
• Device Sequence Number: 21205994
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: (01)10888628043565(10)1002621441(11)240910(17)260810
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 08/10/2026
• Device Catalogue Number: 96183
• Device Lot Number: 1002621441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female