Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.
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Health professional reported that a patient was injected midface and upper face, down to the bone (periosteum), with 3 syringes 1 ml of juvéderm voluma® xc.The patient experiencing ¿tenderness, pain and swelling¿ at the left marionette side, mostly midface 10 weeks later.The area looked like ¿open wounds¿ the patient visited a dermatology office and was treated with hyaluronidase and prescribed unspecified medication.The health professional believed the event of be a ¿biofilm, infection of some type of necrosis.¿ incident and care is under control.The event is ongoing.
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