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

Catalog Number	20089006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported performing ¿a gold needle treatment on a patient, and after the healing period¿ which was one and half month later, the patient was injected with skinvive¿ by juvéderm®.There were no issues after the first treatment; the patient's skin quality significantly improved and there was a noticeable reduction in wrinkles.Sometime later, the patient received a second treatment of skinvive¿ by juvéderm® and after this ¿second application, nodules formed under the skin.¿ despite attempting dissolution procedures, the desired result was not achieved.Symptoms are ongoing.This record captured the 1st injection.
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.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
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.Additional, changed, and/or corrected data: a2, a3a, b3, b5, c1, d4, d6a, h4, h6, h8.
Event or Problem Description
The hcp additionally reported injecting a patient with 1ml of skinvive¿ by juvéderm® in the ¿right side¿ of the face.One month later, the patient was injected with 2ml of skinvive¿ by juvéderm® on both sides of the face.Approximately one month later, the patient went in for examination complaining of a nodule at the eye corners and cheeks.The patient was treated with hyaluronidase into the nodule.The dose was 5-15u per lesion.

• Brand Name: SKINVIVE BY JUVEDERM
• 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: 24665047
• Report Number: 3005113652-2026-00264
• Device Sequence Number: 9227154
• Product Code: LMH
• UDI-Device Identifier: 10840228302763
• UDI-Public: (01)10840228302763(10)1004067496(11)250409(17)270331
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 20089006
• Device Lot Number: 1004067496
• 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
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: Male