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.A review of the device history record has been completed.No deviations or non-conformances were observed.This is a known potential adverse event addressed in the product labeling.
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Patient reported they were injected with juvéderm® ultra plus xc and experienced ¿redness,¿ the area was ¿warm to the touch,¿ and was ¿swollen on the upper left cheek¿ 2 weeks later at the injection site.Patient was treated with ciprofloxacin and symptoms improved.Patient was injected a second time about a month later in the jaw lines bilaterally with an unspecified type of juvéderm® product and, once again, ¿developed redness and warm to the touch and swollen on the upper left cheek, this time not in the injected area, but at the previous area where [they] experienced the adverse events¿ 2 days later.Three days after the second injection, patient was treated with a z-pack.Three days later, area was dissolved with hyalase to ¿get rid of inflammation¿ and symptoms resolved.This is the same event and the same patient reported under mdr id # 3005113652-2020-00046 (allergan (b)(4)).This mdr is being submitted for juvéderm® ultra plus xc.
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