MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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 02/16/2024

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.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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 event of viral infection, deemed not device related is considered an unexpected adverse drug experience.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.

Event Description

Healthcare professional(hcp) reported that a patient was injected with 1ml of juvéderm® voluma¿ xc in the cheeks, 1ml of juvéderm® volbella¿ xc under the eye and 1ml of juvéderm® vollure¿ xc in the nasolabial folds.Four months later, the patient had a fall with a zygomatic fracture and a black eye hematoma, considered not device related.One week later, the patient developed "painful red hard".Patient visited the oral surgeon in pain and the oral surgeon thought was having a reaction.Later, hcp reported that patient experienced stomach virus and loss of consciousness, considered not device related.Patient was treated with medrol dose pack, bactrim oral for 10 days, and injected triamcinolone 10 mg.Symptoms are ongoing.Device has been discarded.This is the same event and the same patient reported under patient identifier (b)(6) ((b)(4)) and (b)(6) ((b)(4)).This emdr is being submitted for the suspect product, juvéderm® vollure¿ xc.

Event Description

Per medical review, the event of viral infection, deemed not device related and is not a serious unexpected adverse drug experience.

Manufacturer Narrative

Previous emdr submission noted the event is a serious unexpected adverse drug experience.Upon further review, abbvie medical safety determined that the event is not a serious unexpected adverse drug experience.Additional, changed, and/or corrected data: b5, g1, h6.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18906201
• MDR Text Key: 337691454
• Report Number: 3005113652-2024-00182
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 95661
• Device Lot Number: 1000552649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White