MAUDE Adverse Event Report: PRINGY SKINVIVE BY JUVEDERM 2X1ML KO; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	20074728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Subcutaneous Nodule (4548)
Date of Event	06/11/2025
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.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported that patient injected with (1cc) juvéderm® voluma® with lidocaine in t1,t2, (3cc) juvéderm® voluma® with lidocaine in the "f", (2cc) juvéderm® volift® with lidocaine in ck1,ck3,ck4, (1cc) juvéderm® volux¿ in c1,c2,c6, (2cc) skinvive¿ by juvéderm® in front cheek (l/r), (1cc) skinvive¿ by juvéderm® in tt1,tt2.Patient experienced "delayed immune response" approximately 2 months after injection.Treatment included unspecified prescription of medication, filler dissolve(filler melt) by using hyalase 4vial and nodulation treatment two round.Symptoms ongoing/unresolved.This is the same event and the same patient reported under patient identifier (b)(6) (emdr-(b)(4), (b)(6) (emdr-(b)(4), (b)(6) (emdr-(b)(4), (b)(6) (emdr-(b)(4), (b)(6) (emdr-(b)(4).This emdr is being submitted for the suspect product, (2cc) skinvive¿ by juvéderm® in front cheek (l/r).
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: h6, h10.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported that patient injected with (1cc) juvéderm® voluma® with lidocaine in t1,t2, (3cc) juvéderm® voluma® with lidocaine in the "f", (2cc) juvéderm® volift® with lidocaine in ck1,ck3,ck4, (1cc) juvéderm® volux¿ in c1,c2,c6, (2cc) skinvive¿ by juvéderm® in front cheek (l/r), (1cc) skinvive¿ by juvéderm® in tt1,tt2.Patient experienced "delayed immune response" approximately 2 months after injection.Treatment included unspecified prescription of medication, filler dissolve(filler melt) by using hyalase 4vial and nodulation treatment two round.Symptoms ongoing/unresolved.This is the same event and the same patient reported under patient identifier (b)(6), (emdr-(b)(4), (b)(6),(emdr-(b)(4), (b)(6), (emdr-(b)(4), (b)(6), (emdr-(b)(4), (b)(6), (emdr-(b)(4).This emdr is being submitted for the suspect product, (2cc) skinvive¿ by juvéderm® in front cheek (l/r).

• Brand Name: SKINVIVE BY JUVEDERM 2X1ML KO
• 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: 22722640
• Report Number: 3005113652-2025-00716
• Device Sequence Number: 9174185
• Product Code: LMH
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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): 08/26/2025

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 Expiration Date: 08/30/2026
• Device Catalogue Number: 20074728
• Device Lot Number: 1002652031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female