MAUDE Adverse Event Report: PRINGY JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	94155
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/06/2025
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 via clinical study injecting a patient 1ml of juvéderm® voluma® xc in the mid-face, juvéderm® ultra xc in the lower lip 0.55ml, and juvéderm® ultra plus xc in the nasolabial folds with 1.5 ml.Patient was given a pre-treatment of topical lidocaine 23% + tetracaine 7% and concomitantly takes trizepatide 2.5mg once a week and adderall 5mg qd.One day post-injection patient experienced a vascular occlusion in the left nasolabial fold.Patient was treated with tylenol 500mg orally and hylenex 300 usp u intramuscularly.Symptoms are ongoing.A 27g 1/2 needle was used.This relates to juvéderm® ultra plus xc.
Event or Problem Description
Healthcare professional additionally reported patient was treated with a topical retinoid.Patient received a v-beam treatment.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b5.
Additional Manufacturer Narrative
Clarification to a6 race: middle eastern.Additional, corrected, and/or changed data: a6, b5, c1, c3, d1, d4, h4, h6.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
Healthcare professional reported via clinical study patient later experienced [non-study device related] low progesterone.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b5, h6.
Event or Problem Description
Healthcare professional (hcp) later noted that the vascular occusion and [non-study device related] low progesterone resolved.Hcp additionally reported one month post-injection, patient experienced acne on the nasal tip.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b7, d10.
Event or Problem Description
Healthcare professional reported via clinical study injecting a patient 1ml of juvéderm® voluma® xc in the mid-face, juvéderm® ultra xc in the lower lip 0.55ml, and juvéderm® ultra plus xc in the nasolabial folds with 1.5 ml.Patient was given a pre-treatment of topical lidocaine 23% + tetracaine 7% and concomitantly takes trizepatide 2.5mg once a week and adderall 5mg qd.One day post-injection patient experienced a vascular occlusion in the left nasolabial fold.Patient was treated with tylenol 500mg orally and hylenex 300 usp u intramuscularly.Patient was treated with 100mg minocycline.Patient later experienced [non-study device related] low progesterone.One month post-injection, patient experienced acne on the nasal tip.Patient was treated with a topical retinoid.Patient received a v-beam treatment.Symptoms are ongoing.A 27g 1/2 needle was used.This relates to juvéderm® ultra plus xc.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 23560747
• Report Number: 3005113652-2025-01041
• Device Sequence Number: 15985688
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)1002671866(11)240718(17)260618
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/29/2026

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 Expiration Date: 06/18/2026
• Device Catalogue Number: 94155
• Device Lot Number: 1002671866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 12/22/2025; 01/07/2026; 01/22/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/06/2026; 01/15/2026; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADDERALL 5MG QD.; CHEMICAL PEELS.; LIDOCAINE 23% + TETRACAINE 7%.; RETINOID FOR ACNE MANAGEMENT.; TRIZEPATIDE 2.5MG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic