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

Catalog Number 95661

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Loss of Vision (2139); Anxiety (2328); Skin Inflammation (2443); Blood Loss (2597); Fluid Discharge (2686)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: clonazepam.(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 ¿purplish color of the skin, blisters, boils, and the left side of my nose blew up, and i looked like a freak¿, ¿swelling¿, ¿blisters filled with fluids, which started draining and getting bigger¿, ¿touched one blister which looked like a pimple and it burst leaving a mass of skin hanging down, later it left a hole in that area¿, and ¿the patient¿sterilized a needle and drained the bumps of clear fluid and flesh¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: adverse events: 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.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.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.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.Instructions for use: 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.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

Patient reported that after an injection in the ¿cheeks, lips, around the mouth, and in each cheek bone¿ with juvéderm vollure¿ xc, they experienced ¿purplish color of the skin, blisters, boils, and the left side of [their] nose blew up, and [they] looked like a freak,¿.Patient also experienced ¿swelling¿, ¿blisters filled with fluids, which started draining and getting bigger.¿ patient ¿touched one blister which looked like a pimple and it burst leaving a mass of skin hanging down, later it left a hole in that area.¿ the patient stated they ¿sterilized a needle and drained the bumps of clear fluid and flesh.¿ patient was treated with hydrocortisone cream, po, and steroids.Treatment with antibiotics are planned, and filler will also be dissolved.Patient is afraid that their face will look deformed.Symptoms are ongoing.This is the same event and the same patient reported under mdr id 3005113652-2018-01613 ((b)(4)).This mdr is being submitted for juvéderm vollure¿ xc (lot # v17la70657).

Event Description

The patient has additionally reported that the injections were performed with the same needle.The patient further described the event as "huge big lumps, purple golf ball like lumps under the eyes on both sides of the nose that are oozing, draining, leaking, infection¿ which have not gone away.The ¿big lumps are filled with fluid¿; ¿between the nose and on the bridge of the nose¿.The needle injection sites remain visible.The patient reported that the area below the nose is great.The patient tried changing eye glasses and that did not help the area under the eyes.During a follow up visit, the healthcare professional ¿pulled on the golf ball like areas and said it was fat¿.Patient cannot wear make-up and ¿is going out of the mind." the ¿golf-balls¿ were treated with moisturizers for dry skin and they did not help.Sunscreen did not make it go away.The zo skin health did not help.The patient uses ¿fresh aloe, freezes it, bangs it and places a piece on the golf balls¿, which helps.The patient has seen 5 cosmetic surgeons and 3 dermatologists for follow up for the ¿purple golf balls¿.The patient reported to have been told to be too old for the product and that the skin has become so thin the product did not have anywhere to go.Patient stated that the product should have been removed but after a year it was too late.The patient reported that if the product is removed now, ¿sagging dead skin would be left and there is no where to tack it¿.The patient alleged that ¿every person injected with the product by the hcp had a reaction¿.The patient alleged that a consent form was never signed.Patient is financially stressed.Patient reported that the product was bad.

Event Description

Additional information: patient called and reported starting three weeks ago, a "bubble" developed on their eyelid and they have "bubbles everywhere." patient reported their entire eyelid is "deeply cut" and there are "holes" in the skin when the bubbles pop.The patient stated they can't see because their eye is swollen shut.The patient also reported "blood pouring from my eyelid" when they were on a treadmill a couple days ago.The patient indicated they received expired product and believes the product is killing them and they "want their life back.".

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Additional information: it was reported that ¿there¿s so much edema¿ and patient ¿didn¿t want to inject hyaluronidase so a cream was provided.Was more inflamed after using cream¿ and ¿it¿s all above the nose.¿ healthcare professional confirmed ¿on exam we didn¿t see anything that appeared abnormal.¿ per different hcp, ¿no palpable material remains¿ and there were no nodules but ¿edema persists.¿.

Event Description

Additional information: patient stated their physician can¿t be trusted and they think they must have bought from some cheap suppliers¿, ¿caller said they had edema on side of nose and it got big that they can¿t see¿, and ¿the caller said they were diagnosed with breast cancer 6 years ago.¿ patient additionally reported they are still experiencing edema and believes the doctor "hit a blood vessel." additional treatment noted as "moisturizers for dry skin, sunscreen, zo skin health, and ¿fresh aloe.¿.

Manufacturer Narrative

Additional information:.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5, h.6.The event of mrsa is an unexpected adverse drug experience.

Event Description

Additional information: consumer also claims ¿they are dying due to being injected with expired botox cosmetic¿, ¿currently suffering with cellulitis in their face and purigo nodularis of the face (believes the negligence of the physician using expired botox and contaminated voluma is the cause of her issues)¿, stated that "[they] are going blind.¿ patient also indicated they were being treated for "mrsa", their entire eyelid is missing¿, ¿totally losing my eyelid¿, ¿tiny raised spots¿ and "stuff coming out of [their] skin" this event is not related to the filler.

• 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: 8116927
• MDR Text Key: 128883286
• Report Number: 3005113652-2018-01706
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70657
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VITAMIN D, THYROID MEDICATION, ADDERALL
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR