MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 04/21/2017

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 infected sebaceous cyst, hard lump and nodules 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 formation of cyst(s), infection and skin irritation: "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.¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.Adverse events a.Clinical evaluation of juvéderm® ultra plus xc ¿ the most common injection site responses for juvéderm® ultra plus xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.C.Other safety data postmarket surveillance the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, which were not observed in the clinical trials; this includes reports received globally from all sources including scientific journals and voluntary reports.All adverse events obtained through postmarket surveillance with a frequency of 5 or more events are listed in order of prevalence: lack or loss of correction, inflammatory reaction at the injection site, skin rash, bleeding at the injection site, allergic reaction, infection at the injection site, migration, paresthesia, vascular occlusion, necrosis at the injection site, abscess at the injection site, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma.In many cases, the symptoms resolved without any treatment.Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress.Inflammatory reaction at the injection site, mostly a nonserious event, has been reported in association with edema, erythema, ecchymosis, pruritus, induration, pain, nodule, blister, abscess, and infection.Time to onset ranged from 1 day to 4 months post juvéderm® ultra plus injection, and outcome ranged from resolved to ongoing at last contact.Interventions prescribed by the health care professionals included topical steroidal cream, oral steroids, and antibiotics.Additional treatment noted was a needle aspiration for drainage of an abscess.Additionally there have been reports of nodules, infection, and inflammation.¿ the onset of nodules generally varied from immediate to 2 months post injection.The treatment prescribed included nsaids, antibiotics, steroids, and hyaluronidase.In most cases nodules resolved within 1 month.¿ the onset of infection generally varied from immediate to 1 month post injection.The treatment prescribed included antibiotics, pain killers, and antibacterial drugs.".

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma® xc and juvéderm® ultra plus xc in the left and right malar regions as well as nasolabial folds.Three months later, the patient had another injection with juvéderm voluma® xc in the malar region and nasolabial folds.About 5 months later, the patient developed an "infected sebaceous cyst" on the left side of the face both below and at the injection site.Patient was reviewed by their dermatologist and who prescribed antibiotics for the patient 3 days later.Patient then later developed a "hard lump/nodule" in the left cheek which was treated with hyaluronidase by the healthcare professional.A week after that, the patient developed a lump on the right cheek and another lump was found in the nasolabial folds a week later.Patient was again treated with hyaluronidase each time.The nodules/lumps were unresponsive to the hyaluronidase treatments.There was no drainage or inflammation present.Patient was also treated with novocain multiple times.The symptoms are improving.This is the same event and the same patient reported under mdr id #3005113652-2017-00506 ((b)(4)) and mdr id #3005113652-2017-00596 ((b)(4)).This mdr is being submitted for the third suspect product, juvéderm® ultra plus xc, also a device manufactured by allergan.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 6671576
• MDR Text Key: 78544470
• Report Number: 3005113652-2017-00597
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)H30LA60131(11)160311(17)170811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2017
• Device Catalogue Number: 94155
• Device Lot Number: H30LA60131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR