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	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected with skinvive¿ by juvéderm® on two seperate 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.
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.The event of "bacterial infection", deemed not device related is considered an unexpected adverse drug experience.

• 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: 24747269
• Report Number: 3005113652-2026-00309
• Device Sequence Number: 13117309
• 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): Fifteen-Day
• 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