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Catalog Number 94154 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Date 06/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.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.
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Event Description
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Patient reports injection with one syringe of juvéderm® ultra xc in the upper lip.Edema, pain and erythema occurred at the injection site (r upper lip).There is a ¿red line inside the upper lip on the right side, its swollen and raw." 2 days post injection, "it got sore, just and got worse, it also burns.¿ etiology noted as vascular occlusion.The patient self-treated with arnica.No diagnostic testing was administered.The symptoms are ongoing.
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Manufacturer Narrative
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Additional data: b.5., h.6.
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Event Description
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Healthcare professional encouraged patient to seek treatment.The patient visited a doctor who didn't do anything and told patient it was a bruise and will go away.According to the patient, "severe pain and swelling on [patient's] upper right lip finally was cured after going to and paying a dermatologist.It did not require hyaluronidases as the swelling was due to having been injected too close to the inner surface of the lip.[patient] still have a lump on the left side of upper lip as well as one on left lower lip.It is already fixed mostly by giving time for healing.It wasn't a fix-it issue.Rather it was incorrect technique that caused the problem." per injector, there was no dissolver needed so there was no vascular occlusion.Symptoms have resolved.
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Search Alerts/Recalls
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