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Catalog Number UNK DERMAL FILLER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Anaphylactic Shock (1703)
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Event Type
Injury
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Manufacturer Narrative
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Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.The event of anaphylactic shock is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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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Patient reported via to a news reporter that they "used to get lip fillers every few months.During one appointment, though, a new solution was used that caused an allergic reaction" a few minutes after injection with unk dermal filler.No brand names were mentioned.The "swelling left patient struggling to breathe" and "could not speak.It was instant, it hit more when the ambulance turned up.They said if i fell asleep, it would kill me.¿.
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Search Alerts/Recalls
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