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

Catalog Number 94155

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

Healthcare professional reported injecting a patient with an unspecified juvéderm®.The patient was concomitantly injected with botox® c.The patient experienced a ¿break out¿ on the side of the face that ¿went away after a couple of months.¿ two years later, the patient was injected in the cheeks, upper lip, and marionette lines with two juvéderm voluma® xc, on syringe of juvéderm vollure¿ xc, and two syringes of juvéderm® ultra plus xc.The patient was again concomitantly injected with botox® c.Ten days later, the patient had a ¿breakout¿ all over the face, their eyes were ¿swollen and crusty,¿ ¿skin was dry and raw,¿ and ¿bumps¿ were reported.The patient visited a dermatologist who confirmed the breakout was due to fillers and said it was an ¿infection.¿ the patient was treated by a family doctor and did not disclose any more information to the injector.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00152 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00153 (allergan complaint #(b)(4)), and mdr id# 3005113652-2022-00154 (allergan complaint #(b)(4)).This mdr is being submitted for the fourth suspect product, juvéderm® ultra plus xc.

• Brand Name: JUVEDERM ULTRA PLUS 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
• 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: 13791261
• MDR Text Key: 287547479
• Report Number: 3005113652-2022-00155
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Catalogue Number: 94155
• Device Lot Number: H30LB00696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM VOLUMA® XC, VOLLURE¿ XC, BOTOX® C
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female