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	Subcutaneous Nodule (4548)
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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.The reporter has declined to provide abbvie further information regarding event, product, or patient details.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a patient was injected with skinvive¿ by juvéderm® on two separate occasions with no incident.Patient later had a third skinvive¿ by juvéderm® treatment and experienced small bumps one month post injection.Hyaluronidase was injected and the bumps resolved.Patient later underwent a fourth treatment with skinvive¿ by juvéderm® and then five months later experienced the similar bumps again with intermittent resolution.About two months after the recurrence of the bumps, patient developed migraines and a sinus infection that required a visit to the er.The bumps have continued to persist.Patient was prescribed prednisone, doxycycline, and iv antibiotics at the er.Event ongoing.

• 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: 24746936
• Report Number: 3005113652-2026-00303
• Device Sequence Number: 21018737
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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 Catalogue Number: 98307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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