Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of discharge 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 discarded.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.Allergan has initiated an investigation into this late report.Capa # (b)(4).
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Healthcare professional reported that patient was injected with 1 syringe of juvéderm® volux¿ in chin, 2 syringes of juvéderm¿ voluma¿ with lidocaine in cheeks and marionette lines, and 1 syringe of juvéderm® volbella® with lidocaine in lips.Three weeks later, patient developed edema, redness, heat, pain that was hard to the touch in chin.An ultrasound was performed in the hospital found no infection, only fluid around filler.Patient took acetaminophen and tylenol® #3.Patient was advised to take reactine® 10mg orally daily for 7 days.The next day, chin appears hard and swollen with red and tender to touch.Serous fluid expelled when chin was punctured.Patient treated with 1500u hyaluronidase in chin and prescribed 20mg prednisone for 1 week.Three days later, little improvement was observed.Patient was treated again with 1500u hyaluronidase and prednisone increased to 30mg daily.Symptoms ongoing.This is the same event and the same patient reported under this is the same event and the same patient reported under mfr report # 3005113652-2021-00492 (b)(4).This emdr is being submitted for the suspect product, juvéderm¿ voluma¿ with lidocaine.
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