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Catalog Number 96637RX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Loss of Vision (2139)
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Event Date 02/06/2022 |
Event Type
Injury
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Event Description
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Healthcare professional reported injecting a patient in the face, middle third, superior third, ck1, ck2, and ck3 with 1 ml of juvéderm® voluma¿ with lidocaine and 50 u of botox®.The patient was pre-treated with lidocaine and aseptine.Two days later, the patient experienced ¿loss of vision and inflammatory process that has increased as time goes by¿ on the face.The patient was treated with nimesulide 100mg, 2x a day, for three days.The event is ongoing.
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformances noted.Based on analyze, the most probable root cause is an inherent hazard of use of the device or wrong medical practices regarding the use of the product.
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Event Description
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Healthcare professional reported injecting a patient in the face, middle third, superior third, ck1, ck2, and ck3 with 1 ml of juvéderm® voluma¿ with lidocaine and 50 u of botox®.The patient was pre-treated with lidocaine and aseptine.Two days later, the patient experienced ¿loss of vision and inflammatory process that has increased as time goes by¿ on the face.The patient was treated with nimesulide 100mg, 2x a day, for three days.The event is ongoing.
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Search Alerts/Recalls
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