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.Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.Adverse events a.Clinical evaluation of juvéderm voluma® xc device/injection-related adverse events occurring in = 1% of subjects included injection site hypertrophy (0.7%), nodule (0.7%), inflammation (0.4%), injection site anesthesia (0.4%), injection site dryness (0.4%), injection site erosion (0.4%), mass (0.4%), contusion (0.4%) and syncope (0.4%).Two subjects (0.7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device.Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye.The subject also experienced nodularity in the right cheek approximately 7 months after treatment.The second subject experienced lumps in the cheeks approximately 7 months after treatment.A couple of days before the onset, the subject experienced myofascial pain and body aches.Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase.All events resolved.".
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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 #3005113652-2017-00596 ((b)(4)) and mdr id #3005113652-2017-00597 ((b)(4)).This is the first mdr submitted for the first suspected product, the second injection with juvéderm voluma® xc.
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