Catalog Number 94506UT |
Device Problem
Off-Label Use (1494)
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Patient Problem
Miscarriage (1962)
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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.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.The event of miscarriage is an unexpected adverse drug experience.
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Event Description
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Health professional reported injecting a patient in the glabellar lines with 3 cc of juvéderm voluma® xc and 1 cc of juvéderm® ultra plus xc.The patient was concomitantly injected with 5 cc of xeomin.The patient was also given anesthesia without consent.The next day, while doing a post-operative follow up, the patient indicated that they suspected that they were pregnant.The patient returned to the injector 6 days later and the pregnancy was confirmed.The patient miscarried that same day.No other information was provided.This is the same event and the same patient reported under mdr id# 3005113652-2019-00938 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm voluma® xc.
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Manufacturer Narrative
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Additional data: g1, h6 a review of the device history record has been completed.No deviations or non-conformances noted.
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Event Description
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Health professional reported injecting a patient in the glabellar lines with 3 cc of juvéderm voluma® xc and 1 cc of juvéderm® ultra plus xc.The patient was concomitantly injected with 5 cc of xeomin.The patient was also given anesthesia without consent.The next day, while doing a post-operative follow up, the patient indicated that they suspected that they were pregnant.The patient returned to the injector 6 days later and the pregnancy was confirmed.The patient miscarried that same day.No other information was provided.
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Search Alerts/Recalls
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