MAUDE Adverse Event Report: Pringy PF Juvéderm Ultra XC 0.55mL/1mL CoC; implant, dermal, for aesthetic use

Catalog Number	96207
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that a patient was injected with 0.1ml of juvéderm® ultra xc in the lip.2 hours later, the patient experienced swelling and blanching in the upper right lip quadrant.The patient was treated with 3 rounds of hylanex, aspirin, a heat pad, bbl c02, and hyperbaric chamber therapy.The event fully resolved after one week.
Event or Problem Description
A healthcare professional reported that a patient was injected with 0.1ml of juvéderm® ultra xc in the lip.2 hours later, the patient experienced swelling and blanching in the upper right lip quadrant.The patient was treated with 3 rounds of hylanex, aspirin, a heat pad, bbl c02, and hyperbaric chamber therapy.The event fully resolved after one week.
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.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b7, d1, d4, d6a, h4, h6, h8.

• Brand Name: PF Juvéderm Ultra XC 0.55mL/1mL CoC
• 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: 50349656
• Report Number: 3005113652-2026-00938
• Device Sequence Number: 17652149
• Product Code: LMH
• UDI-Device Identifier: 10888628044753
• UDI-Public: (01)10888628044753(17)261215(10)1003426836
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• 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,Followup
• Report Date (Section B): 09/16/2026

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: 96207
• Device Lot Number: 1003426836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown