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

Catalog Number	96181
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	03/03/2025
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 hcp reported injecting a patient in the lips with 0.4ml of juvéderm® volbella® xc.Twenty days later, hcp reused the syringe and injected the patient with 0.6ml of juvéderm® volbella® xc in the lips.Patient began to experience "very delayed nodules" about 4 or 5 months post injection.Hcp later reported the patient was prescribed valtrex 1g bid x 7 days for presence of [not device related] cold sore and medrol dose pack for inflammation the same day as symptom onset.Eleven days later, hcp injected the patient with hyaluronidase 50u.Three days later hcp injected the patient with hyaluronidase 65u.Seven days later, hcp injected the patient with hyaluronidase 90u.Prescribed the patient valtrex 1g bid x 7 days for the [not device related] cold sore.Seven days later, hcp injected the patient with hyaluronidase 100u.Patient agreed to start taking prednisone 30 mg x 3 days, 20 mg x 2 days, 10 mg x 2 days.Patient declined further treatment, preferring to "allow [their] body to naturally metabolize".Symptoms are ongoing.The product was transferred to a tb syringe prior to injection.This is the same event and the same patient reported under patient identifier (b)(6).This emdr is being submitted for the suspect product, initial injection in the lips with 0.4ml of juvéderm® volbella® xc.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: h6.
Event or Problem Description
Healthcare professional hcp reported injecting a patient in the lips with 0.4ml of juvéderm® volbella® xc.Twenty days later, hcp reused the syringe and injected the patient with 0.6ml of juvéderm® volbella® xc in the lips.Patient began to experience "very delayed nodules" about 4- or 5-months post injection.Hcp later reported the patient was prescribed valtrex 1g bid x 7 days for presence of [not device related] cold sore and medrol dose pack for inflammation the same day as symptom onset.Eleven days later hcp injected the patient with hyaluronidase 50u.Three days later hcp injected the patient with hyaluronidase 65u.Seven days later, hcp injected the patient with hyaluronidase 90u.Prescribed the patient valtrex 1g bid x 7 days for the [not device related] cold sore.Seven days later, hcp injected the patient with hyaluronidase 100u.Patient agreed to start taking prednisone 30 mg x 3 days, 20 mg x 2 days, 10 mg x 2 days.Patient declined further treatment, preferring to "allow [their] body to naturally metabolize".Symptoms are ongoing.The product was transferred to a tb syringe prior to injection.This is the same event and the same patient reported under patient identifier (b)(6).This emdr is being submitted for the suspect product, initial injection in the lips with 0.4ml of juvéderm® volbella® xc.

• 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: 21893035
• Report Number: 3005113652-2025-00393
• Device Sequence Number: 18167159
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000600429(11)230406(17)250306
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 03/06/2025
• Device Catalogue Number: 96181
• Device Lot Number: 1000600429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic