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

Catalog Number	94154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that a patient was injected with juvéderm® ultra xc in the nlf, 2 syringes of juvéderm® ultra plus xc in the temple, juvéderm® volux¿ xc in the jawline.A few months later the patient complained of pain and wanted filler dissolved.The hcp dissolved the filler with hylenex and scheduled a follow-up on the next day for the patient to get an mri.The results of the mri were no significant findings.A few weeks later the patient went to a neurologist, and they did not recommend any more hylenex due to nerve damage.The patient continued to complain about pain and how it has been impacting their quality of life.This is the same event and the same patient reported under (b)(4).This emdr is being submitted for the serious injury.This is the same event and the same patient reported under patient identifier (b)(6) (b)(4) and (b)(6) (b)(4).This emdr is being submitted for the suspect product, juvéderm® ultra xc.
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.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.The event of "nerve damage" is considered an unexpected adverse drug experience.

• Brand Name: JUVEDERM ULTRA 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: 22162845
• Report Number: 3005113652-2025-00528
• Device Sequence Number: 8842406
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: (01)30888628000081(10)1001415542(11)240308(17)260208
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: 02/08/2026
• Device Catalogue Number: 94154
• Device Lot Number: 1001415542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown