MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Obstruction/Occlusion (2422); Foreign Body Embolism (4439)

Event Date 06/19/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Healthcare professional reported injection to the nasolabial folds with juvederm vista voluma xc (0.6 at the base of the left ala of nose, 0.4 to the right).On the same day, patient presented ¿symptoms of embolism, feeling of heat, pain, purpura¿.Patient was treated with hyaluronidase.The next day, patient was treated with hyaluronidase again and given prednisolone.Event has not resolved.

Manufacturer Narrative

Additional, changed, and/or corrected data: a.2., b.5., b.6., b.7., e.1., g.1., h.6.

Event Description

Additionally, healthcare professional provided affected areas was central forehead, left face, and around mouth.Patient was treated with hyaluronidase, vasodilator drip, prostaglandin ointment for about 8 days after embolism symptoms.It was also noted "use unplug." patient was almost recovered about three weeks after the date of onset.Although there was vasodilation and a little pigmentation under left eye; it became less noticeable.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
• 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: 14877372
• MDR Text Key: 295067783
• Report Number: 3005113652-2022-00401
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female