MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLITE 2X1ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96659RX

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2023

Event Type  Injury  

Event Description

Healthcare professional (hcp) reported that patient was injected with 2ml juvéderm® volite¿ in "generalized facial area, frontal region, malar area, cheeks, and mandibular arch.At the time of application, patient showed no signs of occlusion.One day later, patient developed erythema and ecchymosis in left malar zygomatic region.Two days later, patient developed signs of localized infection on left side injection site, and hcp noted no symptoms of ischemia.Patient was prescribed oral and topical antibiotics.Patient was also treated with 1500iu hyaluronidase total corrector.One day later, patient was treated with 3000iu hyaluronidase total corrector with ultrasound guidance.Ultrasound showed decreased flow and increased thickness of the proximal laterus of the transverse facial artery on left side.Patient has acne scars in zygomatic region.Symptoms are ongoing.

Manufacturer Narrative

Clarification to section c.Suspect product: lot number: 963/2.Continued h.6.Health effect- impact code: f2303.Continued h.6.Type of investigation code: b15, b17, b20.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.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.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.This is a known potential adverse event addressed in the product labeling.

Manufacturer Narrative

Additional, changed, and/or corrected data:b5, h6.

Event Description

Per medical review, the reported symptoms are not the clinical presentation for vascular occlusion and use error.

• Brand Name: JUVEDERM VOLITE 2X1ML ROW
• 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: 17144538
• MDR Text Key: 317336654
• Report Number: 3005113652-2023-00436
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07795316915676
• UDI-Public: 7795316915676
• Combination Product (y/n): Y
• Reporter Country Code: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 96659RX
• Device Lot Number: 1000545368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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: 41 YR
• Patient Sex: Male