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Catalog Number 96657JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burn(s) (1757); Viral Infection (2248)
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Event Date 02/15/2022 |
Event Type
Injury
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Event Description
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Healthcare professional reported injecting a patient in the lips with 0.4 ml of juvéderm® volift® retouch.Ten months later, the patient was injected in the tear trough with 0.3 ml of juvéderm® volift® with lidocaine and botox®.Four months later when patient returned from a trip and reported ¿bilateral palpebral edema¿ in the dark circles and then lips after a sunburn and or a viral infection, deemed not related to the device.It persisted for one month.On examination, it was a little indurated so the patient was treated with solupred 20mg for 7 days then decreased.The patient received additional botox® a month after returning from their trip.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00222.(allergan complaint # (b)(4)).This mdr is being submitted for first the suspect product, juvéderm® volift® retouch.
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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.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.The events of "viral infection" and "sunburn," deemed not related to the device are considered an unexpected adverse drug experience.
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Event Description
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Additionally, the healthcare professional reported currently decreasing corticosteroids and that the event resolved 2 months post-onset.
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Manufacturer Narrative
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Additional, changed, and/or corrected data.A review of the device history record has been completed.No deviations or non-conformances noted.
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Search Alerts/Recalls
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