MAUDE Adverse Event Report: Pringy SKINVIVE by JUVEDERM XC 2x1 mL; implant, dermal, for aesthetic use

Catalog Number	98307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a patient was injected with skinvive¿ by juvéderm® into the right and left malar/zygomatic areas.Patient also concomitantly received nuera and back and cheek laser hair removal.The next day, patient reported presenting with left cheek erythema and good capillary refill.Swelling and mild tenderness also reported.Patient showed slight improvement of erythema each day.Patient was treating area with 2.5% hydrocortisone ointment and biopelle 40 serum multiple times a day.It was noted as of three days after onset the swelling remained and capillary refill was 1-2 seconds.The lower edge of the cheek area was a little darker in color and the redness of the upper edge had resolved by 75%.Patient was prescribed a medrol dose pack, starting with 4 a day then tapering.Patient also given revivisomes, biopelle 40's 2.5% hydrocortisone, doxycycline 100mg.Patient also reportedly rook bacitracin ointment.Patient travelled overseas but returned two weeks later.It was noted the skin had cleared up, good capillary refill and very little erythema.There was a small amount of hyperpigmentation in the lower perinasal area remaining.Patient reportedly had pus coming from the area while overseas.
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 this is a known potential adverse event addressed in the product labeling.

• 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 ; +1(847)936-6324
• MDR Report Key: 50762785
• Report Number: 3005113652-2026-01075
• Device Sequence Number: 13071754
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066(17)Unknown(10)Unknown
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 98307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/14/2026
• 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 Age: 37 YR
• Patient Sex: Male