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 Edema (1820); Erythema (1840); Skin Inflammation (2443)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm® ultra plus xc.(b)(4).Further information from the reporter regarding event has been requested.No additional information is available at this time.The events of swelling, puffy, pimple like sore, soreness, tenderness, redness and bumps are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling for the reported events of edema, erythema, pain, skin inflammation and skin irritation: "6.Adverse events a.Us pivotal study of juvéderm vollure¿ xc the severity and duration of all isrs reported by > 5% of subjects who completed post-treatment diary forms after initial treatment are summarized in table 1 and table 2, respectively.Subjects reported the severity of their isrs as mild, moderate, or severe.Most of the individual isrs were mild to moderate in severity and lasted less than 1 week after initial treatment, asymmetry correction, and repeat treatment with juvéderm vollure¿ xc; some of the isrs lasted 8-30 days.The most common isrs that lasted for 8-30 days after initial treatment were: firmness (42.6%, 46/108), lumps/bumps (36.0%, 36/100), and discoloration (24.2%, 8/33).For most of the individual isr types, subjects reported significantly fewer severe isrs for juvéderm vollure¿ xc than for the control product.The incidence of isrs reported after the asymmetry correction/repeat treatment was generally lower than that reported after initial treatment (table 3).Aes after initial/touch-up treatment occurring in = 5% of nlfs included injection site bruising, erythema, pain, discoloration, pruritus, reaction, and facial asymmetry.In general, aes at the nlfs were mild or moderate in severity for both products, with 49.1% (27/55) mild and 29.1% (16/55) moderate for juvéderm vollure¿ xc.Some aes at the nlfs were severe (21.8%, 12/55).The majority of the aes at the nlfs required no action to be taken (94.5%, 52/55) and resolved without sequelae (98.2%, 54/55).Aes at the nlfs after initial/touch-up treatment that required treatment included swelling treated with antihistamines and nsaids, injection site erythema treated with antibiotics, and skin mass that was biopsied and treated with steroids.One subject had mild injection site swelling that occurred after initial/touch-up treatment and was ongoing at the end of the study.This ae did not require treatment.Three adverse events at the juvéderm vollure¿ xc nlfs occurred weeks to months after the injection procedure.These events included mild swelling, moderate skin mass, and severe itching.Swelling was treated with fexofenadine hydrochloride and ibuprofen, the skin mass was treated with triamcinolone, and the itching did not require any treatment.All 3 events resolved without sequelae.All asymmetry corrections (if needed) and repeat treatments were performed with juvéderm vollure¿ xc.In general, aes at the nlfs after asymmetry correction/repeat treatment were similar to those after initial/touch-up treatment.Within the juvéderm vollure¿ xc randomization group, after asymmetry correction/repeat treatment, 20 aes were reported in 10.8% (10/93) of nlfs, with the most common ae being injection site induration (firmness) in 7.5% (7/93) of nlfs.All other aes occurred in < 5% of nlfs and included injection site mass, pain, bruising, erythema, discoloration, and swelling.A majority of the aes after asymmetry correction/repeat treatment in nlfs originally treated with juvéderm vollure¿ xc were mild (20.0%, 4/20) or moderate (45.0%, 9/20) in severity, required no action to be taken (100%, 20/20), and resolved without sequelae (65.0%, 13/20).Some aes after asymmetry correction/repeat treatment were severe (35.0%, 7/20).After asymmetry correction/repeat treatment, seven aes were ongoing at the end of the study and included injection site induration, mass, swelling, bruising, and discoloration.These aes did not require treatment.There were no serious adverse events related to the treatment reported in the study.On the validated recovery early symptoms module of the face-q questionnaire, the majority of subjects reported feeling not at all or only a little bothered by all 17 symptoms 3 days after initial treatment with juvéderm vollure¿ xc.Subjects reported less discomfort (9.9% for juvéderm vollure¿ xc vs 25.7% for control), tenderness (11.5% vs 30.5%), soreness (10.8% vs 28.9%), and swelling (15.1% vs 40.0%) after treatment with juvéderm vollure¿ xc compared to treatment with the control.For all other symptoms (bruising, tightness, numbness, stinging, burning, throbbing, tingling, itching, tired, feverish, lightheaded, headaches, and pain), subjects reported similar results between juvéderm vollure¿ xc and control.B.European clinical study a prospective, randomized, multicenter study was conducted with 70 subjects treated with juvéderm vollure¿ xc for correction of moderate to severe nasolabial folds.Enrolled subjects exhibited moderate to severe nlf severity scores on the validated 5-point photonumeric nlfss, the same scale as that used for the us pivotal study discussed above.Subjects received treatment with juvéderm vollure¿ xc in both nlfs and received a touch-up treatment at day 14 if optimal correction was not achieved after the initial treatment.Subjects were followed for up to 12 months after the last treatment, returning to the investigational site at regular intervals (months 1, 9, and 12) throughout the study for safety and effectiveness evaluations.All subjects in the study had the option to receive a repeat treatment at the month 12 visit; the subjects were followed for up to 1 month after the repeat treatment.Subjects were monitored throughout the study for any adverse events (aes) by the investigator.Aes that were related to the study device/procedure were recorded.Expected aes, listed in the directions for use (dfu), were only reported as aes if the events were assessed to be more severe or more prolonged than routinely observed.After repeat treatment, subjects completed a 30-day safety diary to record the severity and duration of any injection site responses (isrs).No device/procedure-related ae was observed after the initial/touch-up treatment.Forty-one subjects completed the 30-day safety diary after repeat treatment.The most frequently reported isrs in the diaries were swelling (87.8%, 36/41), firmness (80.5%, 33/41), and tenderness to touch (78.0%, 32/41).The majority of isrs were mild or moderate and resolved within 3 days (table 5).One device/procedure-related ae was observed after repeat treatment.The subject experienced redness around the mouth, swelling, and lower sensibility requiring treatment with corticoid ointment; the ae symptoms resolved in 51 days.8.Instructions for use b.Health care professional instructions 8.The injection technique may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered.Different techniques such as serial puncture, tunneling, fanning, cross-hatching or a combination has been used to achieve optimal results.Injecting the product too superficially may result in visible lumps and/or discoloration.C.Patient instructions it is recommended that the following information be shared with patients: ¿ within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages.Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites.".

Event Description

Healthcare professional reported injecting a patient with juvéderm vollure¿ xc in the marionette lines and juvéderm® ultra plus xc in the diagonal cheek lines and the mid cheeks.A week later, the patient experienced ¿puffy eyelids.¿ patient reported the "swelling" subsided the following day.Approximately 6 weeks later, the patient reported noticing a "pimple like sore" on the left corner of the mouth.Two days later, the patient developed a "pimple like sore" on the right corner of the mouth and experienced "soreness, tenderness, redness, swelling, and can feel ¿bumps" under the skin where the "sores" are located.The symptoms 6 weeks later were attributed to the injection with juvéderm vollure¿ xc in the marionette lines and is unrelated to the injection with juvéderm® ultra plus xc.That day, the patient received hyaluronidase and was prescribed prednisone.Symptoms are ongoing.Patient was concomitantly was taking calcium, vitamin b, vivelle, synthroid and olux foam to the scalp.This is the same event and the same patient reported under mdr id #3005113652-2017-00695 ((b)(4)).This is the first mdr submitted for the first suspected product, juvéderm vollure¿ xc.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6725290
• MDR Text Key: 80458511
• Report Number: 3005113652-2017-00693
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)V17LA70064(11)170210(17)190110
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• 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
• Treatment: CALCIUM, VITAMIN B, VIVELLE, SYNTHROID, OLUX FOAM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR