Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Clarification: "infection", and "migration" are known potential adverse events addressed in the product labeling.
|
Healthcare professional reports a mid-face lift and moderate postoperative contour deformity.Patient was treated with injection of an unspecified juvéderm® product in the mid face.An unspecified amount of time later, unspecified juvéderm® and juvéderm voluma® xc were injected into the midface.The patient experienced ¿product migration, thinning of the skin, increasing contour deformities at areas adjacent to the injections.¿ incision and drainage completed at least 7 times as treatment.The symptoms are ongoing.Permanent damage probable and noted as ¿skin discoloration, seromas, lack of attachment of skin to soft tissues.¿ per healthcare professional, "not only was this deforming psychologically devastating, but [patient] still cannot show face in public." this is the same event and the same patient reported under mdr id# 3005113652-2020-00464 (allergan complaint #(b)(4)) and mdr id# 3005113652-2020-00466 (allergan complaint #(b)(4)).This mdr is being submitted for the second injection with an unspecified juvéderm® product.
|