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

Catalog Number	20073833
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/15/2026
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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting a patient with skinvive¿ by juvéderm® in the left midface with 0.7ml.Immediately post injection, patient experienced "irregular, patchy blanching was observed over the left midface.Capillary refill time (crt) was approximately 1 second.The patient reported no pain, visual disturbance, or abnormal sensation".Blanching resolved spontaneously a few minutes post-injection and evolved into purplish discoloration.Initial symptom management included 750 iu double-diluted hyaluronidase.One hour post-injection, purple color remained, an additional 1200 iu double-diluted hyaluronidase was administered.Crt <2 seconds.Five hours post-injection patient noted mild red-purple discoloration persisted.Sixteen to twenty-four hours post-injection hcp noted the discoloration persisted but "remained stable and non-progressive.Thirty-six hours post-injection patient was asymptomatic and felt normal.Crt <1 second.Persistent "ecchymotic discoloration consistent with bruising/venous congestion.No blistering, necrosis, or neurological signs".Patient is receiving daily low-level red led light therapy.Symptoms are ongoing.

• Brand Name: SKINVIVE BY JUVEDERM 2X1ML ED
• 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: 25351629
• Report Number: 3005113652-2026-00545
• Device Sequence Number: 18753224
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066(17)270131(10)1003474618
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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 Catalogue Number: 20073833
• Device Lot Number: 1003474618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 06/01/2026
• 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