MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLLURE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

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 afterards 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 regimin 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# 3005113652-2022-00699 (allergan complaint #(b)(4)), this mdr is being submitted for the suspect product, juvéderm vollure¿ xc.

Event Description

Additional information reported symptom resolved three weeks after onset.

• Brand Name: VOLLURE (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: 15658633
• MDR Text Key: 302276248
• Report Number: 3005113652-2022-00700
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLLURE
• 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
• 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® VOLUMA¿ XC, BOTOX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female