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 Pneumonia (2011)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

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 of "pneumonia" 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.The event of "pneumonia", deemed not device related is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reporting injecting a patient with a syringe of juvederm® ultra plus xc in the lips and nasolabial fold.Six weeks later, patient was injected again with second syringe of juvederm® ultra xc in the lips and nasolabial fold.Two weeks later, patient experienced a "high fever" and "pneumonia," deemed not device related.No treatment has been provided.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-03259 (allergan complaint #(b)(4)).This mdr is being submitted for the first injection, juvederm ultra plus xc.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.2., b.5, h.6.

Event Description

Additional information reported the patient was hospitalized for the symptoms but unknown what treatment was provided.The event is ongoing.

• 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
• MDR Report Key: 12527186
• MDR Text Key: 273549205
• Report Number: 3005113652-2021-03258
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: 94155
• Device Lot Number: H30LA90533
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR