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 Problems Paralysis (1997); Viral Infection (2248)

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.Clarification: the filler was injected into the patient and syringe was discarded.The syringe was not returned for evaluation.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The events of "covid-19" and bell's palsy" are deemed not device related but are considered unexpected adverse drug experiences.

Event Description

Healthcare professional (hcp) reported that a patient was injected in the lips, nasolabial folds, philthrim, marionette lines with 1 ml of juvéderm® ultra xc and 0.5 ml juvéderm® ultra plus xc.Approximately 2 weeks after injections patient began experiencing symptoms, initially suspected tia (unrelated to the device).Patient saw another provider who suggested it could be bells palsy (unrelated to the device), patient later started exhibiting covid-19 (unrelated to the device) symptoms.Patient developed right facial weakness, right periorbital swelling, right headache, loss of sense of taste.No weakness in extremities.Facial symptoms but not directly correlated to injection sites.Per hcp, event is likely related to bell's palsy.General chemistry, cbc, crp and ct tests completed.Prednisone and valtrex provided as treatment.2 months after injection, patient continues to experience residual facial weakness, particularly to eye lid and mouth on the right side after finishing a course of anti-viral and a burst and taper of steroid.This is the same event and the same patient reported under mdr id# 3005113652-2021-00131 (allergan complaint #(b)(4)).This mdr is being submitted for the 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX ; 7372473605
• MDR Report Key: 11350042
• MDR Text Key: 232860601
• Report Number: 3005113652-2021-00132
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: 94155
• Device Lot Number: H30LA90584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR