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

Catalog Number	94154
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Nodule (4551)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) clarification: 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.Clarification: the event of infection is a known potential adverse event addressed in the product labeling.The event of uti, deemed not device related is considered an unexpected adverse drug experience.
Event or Problem Description
Healthcare professional reported patient was injected about three months ago in the lips with juvéderm® ultra xc.Patient was concomitantly injected with botox®.Patient reported experiencing bruising, swelling of the lips and insisting of having contamination in the injected area.Patient was placed on phrophylactic antibiotic therapy.Patient is still convinced that they has biofilm in lip area and reported experiencing burning, occasional blisters, shedding in the lip area and overall patient reported of not doing well.Biopsy was not provided.Healthcare professional reported they dissolved once.But patient continued to experience headache, white painful nodules on lips, lesions inside of mouth, fatigue, dizziness, anxiousness and burning sensation to face with the additional events that have been deemed device not related of tingling sensation in both arms and legs, floaters in the eyes, spine pain, kidney pain, congestion, slight cough and uti.Patient was seen in the emergency department 5 times with no resolution in symptoms.Patient reported being treated with amoxicillin, macrobid, clindamycin, iv antibiotic, doxycycline, gabapentin and hydrocodone.Patient has had mri of brain, extensive blood work with no findings.The symptoms are ongoing.
Additional Manufacturer Narrative
The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Additionally, the healthcare professional reported that the patient was currently experiencing ¿granuloma¿ in the lips and an ¿untreated vascular occlusion.¿ biopsy was not provided.The event is ongoing.
Event or Problem Description
Per medical review, the reported symptoms are not the clinical presentation for vascular occlusion and use error.

• 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: 15797609
• Report Number: 3005113652-2022-00745
• Device Sequence Number: 11924627
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2023
• Device Catalogue Number: 94154
• Device Lot Number: H24LB10885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 05/04/2023; 05/23/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 05/22/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2021
• 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: ACYCLOVIR, BOTOX®.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Female