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

Catalog Number 95661

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Skin Irritation (2076); Anxiety (2328)

Event Date 05/01/2019

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 events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.These are known potential adverse events addressed in the product labeling.

Event Description

Healthcare professional reported patient was injected with 1 cc of juvéderm vollure¿ xc in the nasolabial folds and oral commissures.5 months later, patient experienced ¿new onset of swelling at the site of filler injections¿.Prior to onset, patient began using intel white, a tooth whitening program that uses topical product on the teeth, and a mouth device placed to hold product in place.¿the device somewhat distorts the mouth while in place¿.Patient noted ¿lines around the mouth¿.A day or 2 later, patient noticed the filler injection sites had ¿popped up¿ with swelling and firmness.On examination, there was mild firmness in the nlfs, and oral commissures.¿no bruising, trauma, fluctuance, erythema¿.Patient was advised to discontinue the intel white, and continue gentle massage and observe.3 days later, patient indicated swelling had dramatically increased.¿the areas were catching [the patient¿s] teeth when they were chewing gum and eating.Patient wanted filler dissolved.The next day, patient reported anxiety associated with continuation in swelling.The next day, patient presented stating that swelling had gotten progressively worse.This was confirmed on examination.It was also noted that there were still no signs of infection, trauma, erythema, or fluctuance.Areas were ¿minimally tender¿.Healthcare professional was ¿uncomfortable¿ injecting hyaluronidase without more information as to what the etiology of this new swelling was.After consulting with other healthcare professionals and some additional research, the healthcare professional determined, patient had ¿granuloma formation¿.Patient was prescribed minocycline 100mg po bid x 4 weeks.After further consultations, patient was prescribed prednisone 10mg-4 per day for 7 days, 3/day x 3 days, 2/day x 2 days, 1/day x 7 days.13 days after onset, patient reported swelling was decreasing.On day 16, patient reported further improvements, but they were now experiencing fatigue and flu-like symptoms.Patient was examined 23 days after onset.No visible swelling.¿minimal firmness at the left nlf about halfway between nasal canthus and lateral mouth¿.No signs of infection.Symptoms are ongoing.

• 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: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8807055
• MDR Text Key: 151588430
• Report Number: 3005113652-2019-00545
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (y/n): N
• 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
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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: 49 YR