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	Nodule (4551)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported that patient was injected in oral commissures and marionette lines with juvéderm® ultra xc.Seven months later, patient was injected in oral commissures, marionette lines, and pre-jowl with juvéderm® ultra xc.Three years later, patient was injected in upper/lower lip lines, oral commissures, and marionette lines with juvéderm vollure¿ xc.Fourteen months later, patient was injected in oral commissures and marionettes lines with juvéderm® ultra xc and in upper lip with juvéderm volbella® xc.One month later, patient was injected in oral commissures and nasolabial folds with 1ml juvéderm® ultra plus xc.One month later, patient was injected in upper lip with juvéderm vollure¿ xc.Twenty months later, patient developed edema in marionette lines.Patient was treated with 0.4cc hylenex®.Six weeks later, patient was treated with 0.4cc hylenex® in oral commissures, marionettes lines, and right nasolabial fold.Six weeks later, patient was treated with 0.3cc hylenex® in oral commissures.One month later, patient was treated with 0.3cc hylenex® in oral commissures.One month later, patient was treated with 0.4cc hylenex® in oral commissures and was prescribed colchicine.The same day, patient was injected in cheeks and nasolabial folds with juvéderm® ultra xc.Two weeks later, patient was prescribed colchicine.Eight days later, patient was prescribed colchicine.Three and a half weeks later, patient was prescribed doxycycline twice.Nine days later, patient was prescribed ciprofloxacin 500mg daily for 14 days.One month later, patient was prescribed medrol dose pack.Approximately two weeks later, patient developed nodules in oral commissures.Patient had biopsy of left oral commissure (2mm); aggregates of exogenous bluish material seen in deep reticular dermis and superficial subcutaneous tissue were found.One week later, patient was treated with 0.2cc hylenex® in each nodule.Two and a half weeks later, patient was treated with 0.2cc hylenex® in each nodule.Three weeks later, patient was treated with 0.15cc hylenex® in each nodule.Three months later, patient was treated with 0.2cc hylenex® in each nodule.Two months later, patient was treated with 0.3cc hylenex® in left nodule.Approximately three months later, patient was treated with kenelog injected into nodules.Symptoms ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00475 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00471 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00472 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00474 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00476 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00477 (allergan complaint #(b)(4)), and mdr id# 3005113652-2022-00478 (allergan complaint #(b)(4)).This mdr is being submitted for the fourth suspect product, juvéderm® ultra xc.

• 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: 15143070
• Report Number: 3005113652-2022-00473
• Device Sequence Number: 14808870
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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: 08/13/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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 VOLBELLA® XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female