MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLBELLA

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

Patient Problems Abscess (1690); Edema (1820)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reports patient injection with juvéderm volbella® xc, juvéderm vollure¿ xc, and juvéderm voluma® xc (5 syringes total) into the midface, prejowl sulcus, marionette, upper cutaneous lip.There were no events during procedure and injector took very good care with aseptic technique.The patient presented 6 days after injection with severe facial swelling and visited the er.The entire face swelled (moon faced) and was very tense.In clinic, patient was not found to have any tenderness, pain, warmness to touch, was afebrile and had no other symptoms besides tense edema.It was later found to be the midface primarily, not the mouth.Patient was placed on doxycycline, high dose antihistamines and cephalexin 2 days post injection.After a few days without relief, prednisone at a dose of 60mg which was been tapering off since was prescribed.The patient is currently on prednisone 5mg every other day.The patient was also experienced fluctuant areas in the midface where juvéderm voluma® xc was injected.Physician drained the affected areas and had them cultured, but nothing grew out (this was performed after antibiotics had been started).The patient completed about 9 days of antibiotics.The physician also injected hyaluronidase in those areas and received in total around 150 units.2 months post injection, patient developed a more "traditional" immune nodule on the lower face where juvéderm vollure¿ xc was applied to the marionette area.Patient treated with weekly hylenex injections to the affected areas.Nodule resolved almost immediately after dissolution and did not recur.Patient remains off prednisone and antibiotics, just on antihistamines.3 months post injection, another fluctuant nodule appeared on the left cheek and was present for 48 hours.Injector completed the "most work" on the patient in this area.1 cc of yellow/white material that appeared to be purulent was aspirated.Treating healthcare professional obtained an excellent sample for another culture when patient had been off of antibiotics for several weeks.An additional culture was completed.Patient is embarrassed about the current state of the face.This is the same event and the same patient reported under mdr id# 3005113652-2020-00454 (allergan complaint #(b)(4)) and mdr id# 3005113652-2020-00452 (allergan complaint #(b)(4)) this mdr is being submitted for the juvéderm volbella® xc injection.

• Brand Name: UNK VOLBELLA
• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10417139
• MDR Text Key: 203645861
• Report Number: 3005113652-2020-00453
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention