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Catalog Number 96183 |
Device Problems
Crack (1135); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/31/2018 |
Event Type
malfunction
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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.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reported one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked".Patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
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Event Description
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Healthcare professional reported one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked." patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
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Manufacturer Narrative
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Device analysis: visual analysis of the device indicates empty syringe of 1.0 ml received with needle still attached to syringe in an opened tray.No defect observed to syringe.
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Search Alerts/Recalls
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