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

Catalog Number	98307
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected with 2mls of skinvive¿ by juvéderm® into the lower face and marionette areas and other products, including sylfirm, and seven months later experienced a bump under the skin in the right lower mandible.Healthcare professional wonders if it could be a possible delayed onset nodule.A ct scan was done about a month and a half after onset noting "dermal thickening".A kenalog injection was performed and event has not resolved.
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 reported a patient was injected with 2mls of skinvive¿ by juvéderm® into the lower face and marionette areas and other products, including sylfirm, and seven months later experienced a bump under the skin in the right lower mandible.Healthcare professional wonders if it could be a possible delayed onset nodule.A ct scan was done about a month and a half after onset noting "dermal thickening".A kenalog injection was performed and event has not resolved.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: h6.

• 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: 24783225
• Report Number: 3005113652-2026-00335
• Device Sequence Number: 6133447
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066(10)1001011203(11)231218(17)251118
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2025
• Device Catalogue Number: 98307
• Device Lot Number: 1001011203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female