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 Pain (1994); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 05/04/2018

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 ¿red small pimple, induration, tenderness, acneic pustule, and swelling¿ 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: ¿product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.¿juvéderm vollure¿ xc injectable gel must not be injected into blood vessels.Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary.Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of stroke, blanching of the skin, or unusual pain during or shortly after the procedure.Patients should receive prompt medical attention and, possibly, evaluation by an appropriate health care professional specialist, should an intravascular injection occur (see health care professional instructions #13).Adverse events: ¿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.¿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.¿aes after initial/touch-up treatment occurring in = 5% of nlfs included injection site bruising, erythema, pain, discoloration, pruritus, reaction, and facial asymmetry.¿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.¿safety endpoints included incidence rates, severity and duration of isrs and aes, subjects¿ assessment of procedural pain, and the recovery early symptoms module of the face-q questionnaire.¿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.Instructions for use: ¿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.¿supplementary anesthesia may be used for additional pain management during and after injection.¿with patients who have localized swelling, the degree of correction is sometimes difficult to judge at the time of treatment.In these cases, it is better to invite the patient back to the office for a touch-up treatment.

Event Description

Health professional reported that a patient experienced red small pimple, induration, tenderness, "acneic pustule¿, and swelling to right marionette area 3 days after they were injected with juvéderm vollure¿ xc in the nlfs/corner of mouth/marionettes and lips.Treatment is noted as clindamycin, cypromycin, vitrase, steroid dosepak, hyaluronidase, and express of pustular material with hyaluronidase administration.Patient developed diarrhea and clindamycin was discontinued.Events are ongoing at this time.

Manufacturer Narrative

Additional information:.

Event Description

Additional information: events resolved three 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: 7695487
• MDR Text Key: 114215851
• Report Number: 3005113652-2018-00863
• 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
• Type of Report: Initial,Followup
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70739
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR