MAUDE Adverse Event Report: PRINGY JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	96181
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional (hcp) reported that a patient was injected with juvéderm volbella® xc and juvéderm voluma® xc.Hcp notes patient called to inform that they thought the filler traveled.When the patient came in there was no redness, swelling, and or lumps felt.The patient was not happy with how it looked, and the hcp requested that they could dissolve it, but the patient declined.On the next day the patient called the office after an hour with extreme swelling to inform them that they went to the er and was prescribed prednisone and antibiotics and was told to get the filler dissolved.The patient was seen by the hcp to schedule an appointment to have the filler dissolved but the patient cancelled the appointment.The patient stated that it was better but still had pockets under their eyes.The hcp recommended that they have lymphatic massaging.So, another follow-up appointment was scheduled.Additionally, the hcp reported that the patient was injected with 2 ml of juvéderm volbella® xc in the infraorbital hollow.The injection site was diffuse.The patient experienced swelling at the periorbital cheeks, and the patient was seen in the er.There was medication provided from hcp as follows: bactrim, prednisone.The patient was recommended to see the hcp for a lymphatic massaging.Symptoms ongoing.This is the same event and the same patient reported under patient identifier (b)(6), (emdr-(b)(4)).This emdr is being submitted for the 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 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.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• 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: 21981234
• Report Number: 3005113652-2025-00437
• Device Sequence Number: 8312893
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000971363(11)230911(17)250811
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 08/11/2025
• Device Catalogue Number: 96181
• Device Lot Number: 1000971363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic