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.This is a known potential adverse event addressed in the product labeling.
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Healthcare professional reported after self-injecting with juvéderm® ultra in the marionette lines, and nasolabial folds, it doesn¿t seem to last.The patient has been injecting the product for years, but now it just didn¿t seem to last.Injections take place in approximately 3-month intervals, and the injector believes they have developed ¿antibodies¿ because their lymph nodes were getting larger.It was noted that they have "few lymph node growth in jawline, some resolved, some still there".This is the same event and the same patient reported under mdr id # 3005113652-2020-00266 (b)(4) mdr id # 3005113652-2020-00267 (b)(4), mdr id # 3005113652-2020-00268 (b)(4), and mdr id # 3005113652-2020-00269 (b)(4).This mdr is being submitted for juvéderm® ultra.
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