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Catalog Number UNK VOLBELLA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cytomegalovirus (CMV) Infection (2220)
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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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of cold sore, deemed not related to the device, is considered an unexpected adverse drug experience.
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Event Description
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Health professional reported injecting a patient in the lips with juv¿derm volbella¿ xc.Four months later, the patient experienced a non-device related cold sore, which activated the filler to produce granulomas.Biopsy not provided.The patient was treated with an antiviral and medrol dosepak.The event resolved.The health professional reported that the same event occurred a year later after an identical treatment.The health professional believes that because the event occurred during the same time of year, maybe allergies are playing a role, maybe histamines are just really high in [the patients] body.This is the same event and the same patient reported under (b)(4).¿this mdr is being submitted for the non-device related event but an unexpected adverse drug experience.
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Search Alerts/Recalls
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