Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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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Healthcare professional reported while injecting a patient with 0.1ml in lower lip of juvéderm® ultra plus, they ¿immediately saw blanching." healthcare professional stopped injecting, massaged with warm compress and pinking indicated recovery.A week later, patient further reported "purpling on chin and sore inside mouth under lip area." healthcare professional thinks it is an occlusion that is beyond treatment and wants to provide wound care but patient is reluctant to come in.¿ event is ongoing.
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