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 Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 05/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm voluma® xc.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 in the lower face and swollen hard bumps around the mouth at the injection sites¿, ¿some kind of allergic reaction¿, ¿face around mouth swollen¿, ¿firm bumps on sides of lips and one above upper lip¿, and ¿one small blister, 1/4", clear¿ 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 new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device labeling: 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.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.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.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 they injected a patient with 1 syringe of juvéderm volbella® xc in the upper lips, and 6 days later, injected 1 syringe of juvéderm vollure¿ xc in the lips and 1 syringe of juvéderm voluma® xc in cheeks.Approximately 2 months later, the patient experienced swelling in the lower face and swollen hard bumps around the mouth at the injection sites.There were no complaints in the cheek area where the juvéderm voluma® xc was injected.The reporter stated ¿it is some kind of allergic reaction.¿ all events were noted as delayed.Healthcare professional stated the patient¿s face around the mouth was swollen and there were some firm bumps on the sides of the lips and one above upper lip.Patient had no pain or itching.One small blister, ¼ inch and clear, also reported.The patient¿s treatment included sleeping with 2 pillows and using a cold washcloth to apply several times a day.The patient was also treated with a medrol dosepak and 2 injections of hyaluronidase which only softened the bumps.The symptoms are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2018-00859 (allergan complaint #(b)(4)).This mdr is being submitted for the second suspect product, juvéderm vollure¿ xc, also a device manufactured by allergan.

Manufacturer Narrative

Additional information:.

Event Description

Symptoms resolved two months after injection.

• 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
• MDR Report Key: 7676227
• MDR Text Key: 113618250
• Report Number: 3005113652-2018-00860
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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 Expiration Date: 10/13/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70719
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HIGH BLOOD PRESSURE MEDICINE, AND SUPPLEMENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR