MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/20/2022

Event Type  Injury  

Event Description

A healthcare professional reported patient was injected with botox (20u in frown lines, 16u in forehead, and 12u/lcl), juvéderm® voluma¿ xc (0.15cc in right cheek and 0.2cc in left cheek) and juvéderm® vollure¿ xc with a cannula (1.5cc in the nasolabial folds).There was some bruising in the patient's left forehead after injections.Six days after injection, patient went hiking wearing a hat and afterwards had a divot in their forehead.It was noted that the divot "was less dented, but more bruised." the next day, there appeared to be more bruising in the supratrochlear artery area.A capillary refill test was conducted on this date noting minimal refill.The next day, patient complained of redness and tenderness on the left eyebrow.Healthcare professional believes this to be a delayed vascular occlusion event coming from the midface injections of the juvéderm® vollure¿ xc.The patient was treated with vitrase (hyaluronidase), hyperbaric o2, and started an aspirin regimen on this day.The next day, patient was again treated with hyperbaric o2.The symptoms noted to be on going but "redness/erythema intact skin improving." this is the same event and the same patient reported under mdr id# 3005113652-2022-00700 (allergan complaint # (b)(4)), this mdr is being submitted for the suspect product, juvéderm voluma® xc.

Manufacturer Narrative

Suspect product: lot number 963/2.(b)(4).Further information regarding event, product, or patient details has been requested.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Additional information reported symptom resolved three weeks after onset.

• Brand Name: JUVEDERM VOLUMA XC 27G 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: 15666310
• MDR Text Key: 302349668
• Report Number: 3005113652-2022-00699
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• 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,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Catalogue Number: 94640
• Device Lot Number: 1000510646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Treatment: JUVÉDERM VOLLURE¿ XC, BOTOX.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female