MAUDE Adverse Event Report: PRINGY UNK JUVEDERM VOLUX; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUX

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

Patient Problems Nodule (4551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  Injury  

Event Description

Healthcare professional (hcp) reported a patient was injected in the cheeks with 1cc of juvéderm® volux¿.11 days later the patient experienced swelling described as nickel sized lump to left mid-malar area with left eye swelling.The patient went to a walk-in clinic and was treated with amoxicillin.Injecting hcp injected the area with 10 units of hyaluronidase.The next day the lump with swelling progressively got worse.The hcp discontinued amoxicillin and started on keflex for 5 days.4 days later swelling to the left side of face improved, but the right side of face started with swelling-similar to the left side of face.Four days later, patient¿s bilateral cheeks were swollen and hard.The patient was unable to sleep on the side due to tenderness.The patient was treated with 150 units of hyaluronidase in the right cheek area.Symptoms ongoing.

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.This is a known potential adverse event addressed in the product labeling.

Manufacturer Narrative

Previous emdr-13127 submission noted the events are a serious injury.Upon further review of abbvie medical safety; it is determined that the events are not considered a serious injury.

Event Description

Per medical review, the events are deemed not a serious injury.

• Brand Name: UNK JUVEDERM VOLUX
• 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 ; FR
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18239794
• MDR Text Key: 329395028
• Report Number: 3005113652-2023-10009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/03/2023
• Supplement Dates FDA Received: 12/12/2023
• 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