MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUX XC 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 20073770

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Viral Infection (2248); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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 covid-19 infection, deemed not device related is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported injecting a patient in the jawline with 1 cc of juvéderm® volux¿ xc.Eighteen days later the patient was injected in the jawline with 1 syringe of juvéderm® volux¿ xc.The next month, the patient contracted non-device related ¿covid¿ for 48 hours with symptoms of ¿ear pain, throat pain, anosmia, loss of taste and a low-grade fever.¿ during this time, the patient began to experience ¿tenderness and swelling¿ at the injection sites and palpable ¿lumps/nodules¿ that were ¿tender and sore to touch¿ and had ¿inflammation¿ in the jawline.The events come and go.Two months later, the patient awoke with ¿discomfort and swelling¿ on both sides of the chin.The patient refused prednisone treatment, so the filler was dissolved with hylenex.Event is ongoing.This is the same event and the same patient reported under abbvie complaint # (b)(6), and emdr-13494.This emdr is being submitted for the first injection with the serious unexpected adverse drug experience.

Manufacturer Narrative

Previous mdr-13622 noted event of covid-19 infection, deemed not device related is considered an unexpected adverse drug experience.However, abbvie medical safety determined this event is not a serious unexpected adverse drug experience.

Event Description

Per medical review, the event of covid-19 infection is not a serious unexpected adverse drug experience.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18263941
• MDR Text Key: 329674453
• Report Number: 3005113652-2023-10026
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20073770
• Device Lot Number: 1000565587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female