MAUDE Adverse Event Report: ALLERGAN (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	Depression (2361)
Date of Event	05/25/2023
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
Patient reported being injected in the ¿gel area down by the chin¿ with 3 syringes of juvéderm® ultra xc.The patient experienced ¿numbness and tingling¿ that stopped 5 months later.The patient described it as ¿very painful¿ and reported being ¿depressed¿ for 2 months.The filler was dissolved but the numbness remained.The patient reported that another healthcare professional thought it might be ¿partial vascular occlusion.¿ event is ongoing.
Additional Manufacturer Narrative
Clarification to section c.Suspect product: lot number 963/3.Continued h.6.Type of investigation code: b18.Clarification to h.6.Type of investigation code: the syringe has been discarded.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
Additionally, the healthcare professional reported injecting the patient in the chin and jawline with 3 ml of juvéderm® ultra xc.Ten days later, the patient complained of ¿heaviness¿ in the right marionette/jowl and a ¿tingly, numb¿ feeling, mostly at night.The patient was ¿still bruised and swollen¿ and insisted on having all the filler removed.The patent consented to only having the filler removed in the right jowl/marionette with 50 u of hylenex that day.Five days later, the patient reported still feeling ¿intermittent tingling.¿ the next day, the patient presented with ¿light shadow of bruising on the right jowl¿ and it was agreed that there were no signs of vascular occlusion.Eleven days later, the event resolved and the patient reported 9 days later that ¿bruising is much better, almost gone.¿.

• Brand Name: JUVEDERM ULTRA XC TSK US
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18119318
• Report Number: 3005113652-2023-00892
• Device Sequence Number: 18020521
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 11/29/2023
• Device Catalogue Number: 94154
• Device Lot Number: 1000533480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORTISONE, BLOOD THINNERS,ZOLPIDEM, PREMAR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female