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

Catalog Number 20073770

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

Suspect product: lot number 963/2.The filler was injected into the patient and is not accessible for return.The syringe has been discarded.The event is a physiological complication and analysis of the device generally does not assist allergan 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 infection is a known potential adverse event addressed in the product labeling.The event of extrusion is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported injecting a patient along the jawline with 2 cc of juvéderm® volux¿ xc.The patient ¿nodule-like bumps that when express, filler comes out.¿ it was noted that the event is ¿looking infected.¿ the event began 2 weeks later, with 1 nodule close to the chin ¿where the cannula would have stopped.¿ the patient ¿popped it and filler came out.¿ a week and a half later, 2 more lumps appears, 1 at the bottom of the jaw and 1 close to the ear.A month after injection, the patient was given keflex 3x day 500 mg x 10 days and a medrol dosepak.Once the treatment is done they may dissolve if necessary.Event is ongoing.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16710509
• MDR Text Key: 313006619
• Report Number: 3005113652-2023-00233
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30840228300077
• UDI-Public: 30840228300077
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: 1000543811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG