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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.The event of extrusion is considered an unexpected adverse drug experience.
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Health professional reported injecting a patient in the c1, c4, jw4, and jw5 with 3 ml of juvéderm® volux¿.The patient was given paracetamol post-injection.The patient reported an ¿escape of orange gel¿ 10 days later with ¿redness and pain (inflammation)¿ in the chin area 15 days later.The patient was treated with 13 days post-injection with ciflox clarithromycin for 2 weeks.The resolution of event was noted as "in progress of resolution.".
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