MAUDE Adverse Event Report: PRINGY SKINVIVE BY JUVEDERM XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	98307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting a patient with 1cc of juvéderm® voluma® xc in the cheeks, and 2cc of skinvive¿ by juvéderm® in the cheeks.Patient concomitantly received 3 syringes of non-abbvie versa in the chin and cheeks, as well as 6u of botox in the chin.Two years later, patient received a series of nouvaderm laser treatments with exoie plant exosomes.The second occurred two months later using the nouvaderm 1927 fractionated laser treatment.The third and final treatment occurred about two months later where the patient received a vi purify with precision plus after the nouvaderm laser.Approximately two weeks later, patient contracted covid which triggered swelling in the glabella, under eyes, and left chin/jawbone.Patient did not originally believe the symptoms were related to the filler injections 2 years prior.Patient had an mri performed.Patient noted a nodule on the chin, later described by the hcp as a granuloma.Hcp noted granulomas seem to be "in [the] glabella ( [hcp] didn¿t put any filler there but did treat [the patient] with botox there" as well as in the under eye area, near the "medial cheek almost in the tear trough, and on [the] right jaw".Symptoms are ongoing.This relates to skinvive¿ by juvéderm®.
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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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: SKINVIVE BY JUVEDERM XC 2X1 ML
• 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: 24736200
• Report Number: 3005113652-2026-00300
• Device Sequence Number: 18690040
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066(10)1000524565(11)220629(17)240529
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 05/29/2024
• Device Catalogue Number: 98307
• Device Lot Number: 1000524565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Female