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

Catalog Number 95661

Device Problem Migration (4003)

Patient Problem Skin Irritation (2076)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

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 a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek" and induration 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: adverse events: 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.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).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.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.Instructions for use: 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.

Event Description

Healthcare professional (hcp) called to report a patient was injected with juvéderm voluma® xc in the cheeks and juvéderm vollure¿ xc in the nasolabial folds in seven months ago.The patient additionally received restylane in last year in the nasolabial folds.The patient presented to the office today with a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek." hcp indicated it is one big nodule the size of a golf ball that has gotten bigger (closer to a baseball).The patient was treated with hylenex.No other information provided.This record will be in reference to injection with juvéderm vollure¿ xc.Symptoms remain ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2018-01348 (allergan complaint # (b)(4)).This mdr is being submitted for juvéderm vollure¿ xc (lot v17la70719).

• 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: 7991297
• MDR Text Key: 124566029
• Report Number: 3005113652-2018-01349
• 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: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• 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: JUVÉDERM VOLUMA® XC IN THE CHEEKS
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR