(b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events of "redness, swelling, and white papules " are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: intended use/indications: juvéderm® ultra xc injectable gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).Juvéderm® ultra xc is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.Warnings: injection site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting = 7 days in facial wrinkles and folds, and typically last = 14 days in the lips.Refer to the adverse events section for details.Adverse events: the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.Table 1 and 2.Injection site responses by maximum severity and duration.Possible treatment site responses: redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration.Postmarket surveillance: the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, 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 adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, 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.
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