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 "movement of the product to the superficial dermis," "extrusion and intermediate rejection," nodule, "product is coming out in spurts," and "permanent impairment" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: "precautions: ¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Adverse events: per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n = 265) possible treatment site responses post injection with juvéderm voluma® xc include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.Treatment site responses reported by [less than or equal to] 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness.Device- and injection related adverse events occurring in [less than or equal to] 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%).Post-market surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® with lidocaine has been marketed outside the us since 2009.As of december 31, 2012, the following aes were received from post-market surveillance for juvéderm voluma® with and without lidocaine with a frequency [greater than or equal to] 5 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 post-market surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, granuloma, allergic reaction, abscess, necrosis, numbness, and vision abnormalities.Reported treatments include: antibiotics, steroids, hyaluronidase, anti-inflammatories, anti-histamines, aspiration, radio frequency therapy, laser treatment, ice, massage, warm compress, analgesics, anti-viral, ultrasound, excision, drainage, and surgery.".
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