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

Catalog Number 94154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm voluma® xc.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.The event of urinary tract infection, deemed not related to the device, is considered an unexpected adverse drug experience.

Event Description

Health professional reported injecting a patient in the cheeks with 1 cc of juvéderm voluma® xc and in the lips and nasolabial folds with 1 cc of juvéderm® ultra xc.The patient experienced a ¿nodule¿ in the right cheek and returned to the office a month after injection where ¿nodules and edema¿ were confirmed.The patient was treated with 5fu 50 ml and a steroid pack.The patient returned a week later with more ¿nodules¿ in the right cheek.The patient was treated 150 ml of hylenex, antibiotics, and a steroid injection.Two weeks later, the patient was treated with 100 ml of hylenex.The patient was currently on an antibiotic for a non-device related urinary tract infection.Three weeks later, the patient reported the nodules were worsening in the right cheek and ¿facial palsy (not related to the device)" on the right side.The patient has a previous injection in the marionette lines with juvéderm vollure¿ xc and experienced ¿an infection with an abscess¿ that had to be drained.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00785 (allergan complaint # (b)(4)) and mdr id# 3005113652-2020-00783 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra xc.

Manufacturer Narrative

Additional, changed, and/or corrected data: h.6.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Health professional reported injecting a patient in the cheeks with 1 cc of juvéderm voluma® xc and in the lips and nasolabial folds with 1 cc of juvéderm® ultra xc.The patient experienced a ¿nodule¿ in the right cheek and returned to the office a month after injection where ¿nodules and edema¿ were confirmed.The patient was treated with 5fu 50 ml and a steroid pack.The patient returned a week later with more ¿nodules¿ in the right cheek.The patient was treated 150 ml of hylenex, antibiotics, and a steroid injection.Two weeks later, the patient was treated with 100 ml of hylenex.The patient was currently on an antibiotic for a non-device related urinary tract infection.Three weeks later, the patient reported the nodules were worsening in the right cheek and ¿facial palsy (not related to the device)" on the right side.The patient has a previous injection in the marionette lines with juvéderm vollure¿ xc and experienced ¿an infection with an abscess¿ that had to be drained.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00785 (allergan complaint # (b)(4)) and mdr id# 3005113652-2020-00783 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra xc.

• Brand Name: JUVEDERM ULTRA XC TSK US
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 11043565
• MDR Text Key: 222645460
• Report Number: 3005113652-2020-00782
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2020
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENBREL, STEROIDS; ENBREL, STEROIDS
• Patient Outcome(s): Required Intervention