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

Catalog Number	20089006
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Abscess (1690); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient, who is a healthcare professional, reported self-injecting in the midface with 1 syringe of skinvive¿ by juvéderm®.The next day, the patient experienced ¿bumps¿ superficially, a ¿red/pinkish rash,¿ and ¿inflamed skin and pustules¿ around/close to the injection site, at the left cheek.The redness reached 1 cm around the site.The patient was treated with dye vl laser, and red-light therapy.Event is 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.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 completed.No deviations or non-conformance's noted.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
Upon further review, the previously reported event of abscess is actually inflammation/irritation.All previous adverse events is consistent with an inflammatory reaction.Additional, changed, and/or corrected data: b5, h1, h6.
Event or Problem Description
Per medical review, the event is consistent with an inflammatory reaction.Although laser and light therapy were provided, these are cosmetic procedures and were not administered to preclude permanent harm or injury.

• 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: 24299564
• Report Number: 3005113652-2026-00119
• Device Sequence Number: 21427931
• Product Code: LMH
• UDI-Device Identifier: 10840228302763
• UDI-Public: (01)10840228302763(10)1004327031(11)250623(17)270531
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 1004327031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 55 KG