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

Catalog Number	94155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported that a patient was injected in the malar cheeks and jawline with 1 ml of juvéderm® voluma¿ xc, in the vermillion lip and superior cutaneous lip with 1 ml of juvéderm® volbella¿ xc, and in the nasolabial folds with 1 ml of juvéderm® ultra plus xc.Six months later, the patient reported ¿swollen, sore, pink nodules¿ at the malar cheeks and superior cutaneous lip.That same day, the patient was prescribed lisinopril 5 mg for 5 days.The patient returned 6 days later with little improvement and was told to continue lisinopril 5 mg for 7 more days.After the 7 days, the patient returned with little improvement and the lisinopril was upped to 10 mg for 7 days, with a medrol dosepak and a round of doxycycline added.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00318 (allergan complaint # (b)(4)) and mdr id# 3005113652-2022-00319 (allergan complaint # (b)(4)).This mdr is being submitted for the third suspect product, juvéderm® ultra plus xc.
Additional Manufacturer Narrative
Concomitant medical products: botox®.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was 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.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): 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14650791
• Report Number: 3005113652-2022-00320
• Device Sequence Number: 5720091
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 04/17/2022
• Device Catalogue Number: 94155
• Device Lot Number: H30LB00993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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: JUVÉDERM® VOLUMA¿ XC, JUVÉDERM® VOLBELLA¿ XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female