Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE |
Device Problem
Off-Label Use (1494)
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Patient Problem
Necrosis (1971)
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Event Date 04/01/2020 |
Event Type
Injury
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Event Description
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Healthcare professional reported a patient ordered juvéderm® voluma¿ over the internet and self-injected in the lips after viewing internet video tutorials.Following the injection, an adverse event of "persistent deformation of the lips for more than 20 months" was immediately noted.8 weeks following the injection, there was bruising and major oedema away from the injection site with "distension of the mucosa with persistent edema and loss of shape of the upper lip." patient also had social embarrassment after they performed the injection.Current state of the patient was noted no knowledge of the risks for "necrosis, cessation, deformations.".
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Manufacturer Narrative
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The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of necrosis is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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 a patient ordered juvéderm® voluma¿ over the internet and self-injected in the lips after viewing internet video tutuorials.Following the injection, an adverse event of "persistent deformation of the lips for more than 20 months" was immediately noted.8 weeks following the injection, there was bruising and major oedema away from the injection site with "distension of the mucosa with persistent edema and loss of shape of the upper lip." patient also had social embarassment after they perfomed the injection.Current state of the patient was noted no knowledge of the risks for "necrosis, cessation, deformations.".
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Event Description
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Additional details received noting that 1ml of product was injected and packaged needle was used.
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Search Alerts/Recalls
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