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Catalog Number 95661 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Viral Infection (2248); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2024 |
Event Type
Injury
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Manufacturer Narrative
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Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.The event of viral infection, deemed not device related is considered an unexpected adverse drug experience.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.
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Event Description
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Healthcare professional(hcp) reported that a patient was injected with 1ml of juvéderm® voluma¿ xc in the cheeks, 1ml of juvéderm® volbella¿ xc under the eye and 1ml of juvéderm® vollure¿ xc in the nasolabial folds.Four months later, the patient had a fall with a zygomatic fracture and a black eye hematoma, considered not device related.One week later, the patient developed "painful red hard".Patient visited the oral surgeon in pain and the oral surgeon thought was having a reaction.Later, hcp reported that patient experienced stomach virus and loss of consciousness, considered not device related.Patient was treated with medrol dose pack, bactrim oral for 10 days, and injected triamcinolone 10 mg.Symptoms are ongoing.Device has been discarded.This is the same event and the same patient reported under patient identifier (b)(6) ((b)(4)) and (b)(6) ((b)(4)).This emdr is being submitted for the suspect product, juvéderm® vollure¿ xc.
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Event Description
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Per medical review, the event of viral infection, deemed not device related and is not a serious unexpected adverse drug experience.
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Manufacturer Narrative
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Previous emdr submission noted the event is a serious unexpected adverse drug experience.Upon further review, abbvie medical safety determined that the event is not a serious unexpected adverse drug experience.Additional, changed, and/or corrected data: b5, g1, h6.
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Search Alerts/Recalls
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