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

Catalog Number	94155
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Necrosis (1971); Obstruction/Occlusion (2422)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient 0.8ml to the lips and 0.2ml to the chin cleft using juvéderm® ultra plus xc.Patient had previously received 1ml juvéderm® voluma® xc chin filler and 1ml juvéderm® ultra plus xc nasolabial fold one year earlier.Patient experienced a vascular occlusion "intraorally under [the] tongue".Hcp noted they checked aspiration prior to each injection.Hcp later reported the patient initially experienced right-sided jawline pain immediately post-injection.Patient reported to hcp they were exposed to an unspecified "viral illness" which they experienced "similar symptoms, including pain radiating from the ear into the teeth and jaw".Three days later, patient reported they were "overall doing well but noted development of a canker sore beneath [the] tongue".Hcp reviewed photos of the patient and reported "concerning signs of intraoral necrosis".Hcp noted upon in-office examination of the patient a 3cm area of blanching.Patient was treated with hylenex injection, 12 vials into the submental, mental foramen, and cleft chin, sildenafil 25mg po, asa 325mg po, warm compress, massage, and red light therapy.The following day patient was treated with hylenex injections 3 vials to submental area, sildenafil 25mg po, asa 325mg po, warm compress, massage, red light therapy.Patient was instructed to continue management of symptoms with sildenafil 25mg po, asa 325mg po, warm compresses, chlorhexidine mouth was tid, magic mouth wash (diphenhydramine, maalox, and viscous lidocaine) as needed, "difliuan" 150mg po and nyastatin mouth wash.Symptoms resolved sixteen days post-onset.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a2, a4, a5, a6, b2, b3, b5, b7, c1, c3, d1, d4, d6a, h4, h6, h8.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 (hcp) reported injecting a patient in the lips and 0.2cc in the chin with juvéderm® ultra plus xc.Patient experienced a vascular occlusion "intraorally under [the] tongue".Hcp noted they checked aspiration prior to each injection.Symptoms are ongoing.
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.

• 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: 24611493
• Report Number: 3005113652-2026-00252
• Device Sequence Number: 10225051
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)1002793217(11)241020(17)260920
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Expiration Date: 09/20/2026
• Device Catalogue Number: 94155
• Device Lot Number: 1002793217
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White