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 events of "asthma, bronchitis and pneumonia" are deemed not device related but are considered unexpected adverse drug experiences.
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Healthcare professional reported a patient was injected with 1.0 cc of juvéderm voluma® xc and 1.0 cc of juvéderm volbella® xc in the cheeks and nasolabial.Five months later, patient was injected with 1.0 cc juvéderm voluma® xc in the cheeks.Seven months later, patient was injected with 1.0 cc juvéderm® ultra plus xc in cheeks.Approximately seven months later, patient developed asthma, pneumonia, and bronchitis and was given prednisone on a tapering regiment for 6 months, deemed not related to the device.Three months later, patient was injected with 1.0 cc juvéderm voluma® xc in the checks and 1.0 cc juvéderm volbella® xc in the infraorbital hollow.Three months later, patient developed firmness throughout the cheeks and watery edema in the malar bag region.Patient was treated with doxycycline and hylenex® was administered to remove some product from the cheeks ¿ this improved the edema slightly.Patient has weekly assessments at clinic and is also taking singulair®.Patient is taking alternating doses of 2 and 4mg prednisone od.It was also noted that patient had restylane on an unknown date and have had other unknown fillers in the past six years.Symptoms are improving but ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-00046 (allergan complaint #(b)(4)), mdr id# 3005113652-2021-00026 (allergan complaint #(b)(4)), and mdr id# 3005113652-2021-00041 (allergan complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvéderm voluma® xc.
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