Catalog Number 94154 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Dyspnea (1816)
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Event Date 06/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: topical lidocaine in perioral area.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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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Event Description
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Healthcare professional reported injecting 1 ml of juvederm® ultra in the patient's lips.The patient was concomitantly given 2%lido/nabicarb in the periform aperture and topical lidocaine in the perioral area.24 hours later the patient began experiencing "shortness of breath." two days later the patient went to the er for "swelling in the lips, pain, and shortness of breath." patient was prescribed prednisone, 10 mg (4 pills for 4 days), for the symptoms.The filler was dissolved but swelling / pain have not been resolved.
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Manufacturer Narrative
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A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
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Event Description
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Additional information clarified that the filler was not dissolved, but the symptoms have resolved.
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Search Alerts/Recalls
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