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.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
|
Health professional (hcp) reported concomitantly injecting a patient with 1 syringe of juvéderm® ultra plus xc, 1 syringe of juvéderm vollure¿ xc, and 18 units of botox®.3 days later, the patient reported experiencing ¿anxiety, headache, labile emotional state and depression.¿ the patient went to the emergency room and was treated with unspecified anxiety medications and discharged.The hcp added that ¿the patient doesn¿t want to get dependent on the medications¿.The patient reported being ¿okay when working¿, but ¿as soon as [the patient] leaves to get in [the] car, [the patient] gets emotional and wants the fillers out.¿ the patient has no history of anxiety or depression.The symptoms have not resolved.This is the same event and the same patient reported under mdr id # 3005113652-2019-00530 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra plus xc, also a device manufactured by allergan.
|