ALLERGAN (PRINGY) JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE
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Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Date 10/18/2020 |
Event Type
Injury
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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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Health professional reported injecting a patient in the nose with juvéderm® voluma¿.The injection site was reported ¿a little bit pinkish,¿ which the injector suspects to be ¿vascular suffering.¿ during the night, the patient experienced ¿huge pain¿ at the injection site.The patient was treated with a warm compress the next day, which seemed to give the patient relief, but ¿a darker color change¿ in the area is observed in the morning.
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Search Alerts/Recalls
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