(b)(4).In response to fda report number mw5072181.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.The events of ¿large cheek granulomas¿ and ¿discomfort and disfigurement¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.Device labeling: 4.Warnings ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks.Refer to the adverse events section for details.5.Precautions.¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.6.Adverse events a.Clinical evaluation of juvéderm voluma® xc per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment, possible treatment site responses post injection with juvéderm voluma® xc include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration and itching.Postmarket surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013.The following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.
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