MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUX CANADA; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95294ZQ

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

Patient Problem Tachycardia (2095)

Event Date 11/26/2020

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.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 tachycardia (not device related) is considered an unexpected adverse drug experience.

Event Description

Health professional reported injecting a patient in the chin and jawbone with juvéderm® volux¿.Fourteen days later, patient reported edema and pain at injection sites with additional events deemed not related to the device of "hein¿, left face, masseter and parotid region and difficulties eating.The patient was treated with cortisone.Five days later, the cortisone treatment was stopped due to ¿whole face redness and tachycardia,¿ deemed not related to the device.The patient was treated with klaricid 500mg, hyaluronidase, and clarithromycin.Six days later, an ultrasound was performed, which noted ¿abscess in the masseter muscle, which was related to dental treatment that patient was receiving,¿ deemed not related to the device.An ultrasound guided puncture was performed and almost 4 ml of a very viscous liquid (like a gel), pus colored, was removed.The material was sent for fungus and bacteria research.The event is ongoing.

Event Description

Health professional reported injecting a patient in the chin and jawbone with juvéderm® volux¿.Fourteen days later, patient reported edema and pain at injection sites with additional events deemed not related to the device of "hein¿, left face, masseter and parotid region and difficulties eating.The patient was treated with cortisone.Five days later, the cortisone treatment was stopped due to ¿whole face redness and tachycardia,¿ deemed not related to the device.The patient was treated with klaricid 500mg, hyaluronidase, and clarithromycin.Six days later, an ultrasound was performed, which noted ¿abscess in the masseter muscle, which was related to dental treatment that patient was receiving,¿ deemed not related to the device.An ultrasound guided puncture was performed and almost 4 ml of a very viscous liquid (like a gel), pus colored, was removed.The material was sent for fungus and bacteria research.The event is ongoing.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: JUVEDERM VOLUX CANADA
• 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: 11069370
• MDR Text Key: 223590577
• Report Number: 3005113652-2020-00814
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 95294ZQ
• Device Lot Number: V25LB00158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR