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

Catalog Number UNK VOLLURE

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of ¿swelling and tenderness over entire face and all injected sites,¿ "lesion," ¿immunologic reaction/general histamine reaction," and ¿firm¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: 4.Warnings ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting = 30 days.Refer to the adverse events section for details.5.Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.¿ patients may experience late-onset adverse events with use of dermal fillers, including juvéderm vollure¿ xc.Refer to adverse events section for details.6.Adverse events table 1 and 2.Injection site responses by maximum severity and duration in > 5% of subjects after initial treatment.Possible treatment site responses include: firmness, swelling, tenderness to touch, lumps/bumps, redness, pain after injection, bruising, itching and discoloration.C.Postmarket surveillance juvéderm vollure¿ xc has been marketed outside the us since 2011 as juvéderm volift® with lidocaine.The following aes were received from postmarket surveillance on the use of juvéderm vollure¿ xc outside the united states and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.These aes, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, skin nodule, loss/lack of correction, hematoma, allergic reaction, necrosis, infection, flu-like symptoms, paresthesia, migration of device, abscess, drainage, herpes, malaise, headache, and anxiety.In addition, 1 report of blurry vision after injection in the periorbital area, 1 report of blurry vision after injection in an unspecified area, and 1 report of stroke after injections in an unspecified area with multiple dermal fillers were reported.In many cases the symptoms resolved without any treatment.Reported treatments for these events included the use of (in alphabetical order): analgesics, anesthetics, antibiotics, anti-allergy medications, antifungal, antihistamines, anti-inflammatory medications, antiviral, arnica, aspiration, drainage, hyaluronidase, ice, massage, nitrates, oral and topical corticosteroids, and warm compress.Outcomes for these reported adverse events ranged from resolved to ongoing at the time of last contact.

Event Description

Healthcare professional reported a patient was injected with 1 syringe of juvéderm voluma® xc in cheeks and marionettes.Twenty eight days later they were injected with 1 syringe of juvéderm volbella® xc in perioral area and with juvéderm® ultra plus in nasolabial folds.Approximately 6 weeks later, the patient was injected with 1 syringe of juvéderm volbella® xc in perioral area as a touch up treatment.Two weeks after that, the patient was injected with 1 syringe of juvéderm vollure¿ xc in marionettes and nasolabial folds and with half syringe juvéderm voluma® xc in cheeks.About 3 weeks later, the patient was injected with juvéderm® (unspecified) in temples, and half syringe of juvéderm voluma® xc in cheeks and marionettes.Approximately 4 months later, the patient was injected with 1 syringe juvéderm volbella® xc in lips and with 1 syringe juvéderm voluma® xc in cheeks, nasolabial folds, and marionettes.About 4 months later, the patient received hormone pills and the patient began taking sulfur supplements during this time.Two days after taking the hormone pills and sulfur supplements, the patient experienced swelling and tenderness over entire face and all injected sites.Not red, just firm and swollen.Tender from the swelling.No fever.Five days later, healthcare professional advised the patient to stop taking sulfur supplement and to take benadryl and medrol.Symptoms improved, but recurred after stopping treatment.Antibiotics (minocycline) and a steroid (prednisone) taper prescribed at an unknown time.Healthcare professional stopped steroid treatment half way through due to patient reaction to it.Approximately a month later, medrol was prescribed again and 3 vials hylenex were injected.Six days later, 2 more vials hylenex were injected.The results presented minimal improvement.Twelve days later, triamcinolone and 5fu injected into patient.Healthcare professional saw improvement.Three days later, the patient's swelling returned.At an unspecified time, the patient saw allergist who believes this to be a general histamine reaction unrelated to fillers.The patient was prescribed 2-month course of steroids.This record represents the juvéderm vollure¿ xc in marionettes and nasolabial folds that was concomitantly injected with the half syringe of juvéderm voluma® xc in the cheeks.This is the same event and the same patient reported under mdr id#s 3005113652-2018-01010 ((b)(4)), 3005113652-2018-01011 ((b)(4)), 3005113652-2018-01012 ((b)(4)), 3005113652-2018-01009 ((b)(4)), 3005113652-2018-01014 ((b)(4)), 3005113652-2018-01015 ((b)(4)), 3005113652-2018-01016 ((b)(4)), 3005113652-2018-01017 ((b)(4)), 3005113652-2018-01018 ((b)(4)).This mdr is being submitted for another suspect product, juvéderm vollure¿ xc, also a device manufactured by allergan.

• 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 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7785543
• MDR Text Key: 117188078
• Report Number: 3005113652-2018-01013
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLLURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/15/2018
• 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: HALF SYRINGE JUVÉDERM VOLUMA® XC IN CHEEKS
• Patient Outcome(s): Required Intervention