Catalog Number 96183 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/18/2019 |
Event Type
malfunction
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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.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 that prior to injection with one syringe of juvéderm® volbella® xc, ¿the injector didn¿t get any product out of the syringe because of a crack was found in the grey stopper of the plunger.The injector didn¿t want to inject the patient with a crack in the syringe because of possible contamination.¿.
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Manufacturer Narrative
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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.Device evaluation: "1.0 ml syringe filled at 0.55 ml with 0.4 m of gel remaining in it received with a cap, 2 unused needles in an opened tray.A crack is observed at the 3 mm luer lock level.Syringe has been used as some gel is present in the luer lock and on cap.".
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Event Description
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Healthcare professional reported that prior to injection with one syringe of juvéderm® volbella® xc, ¿the injector didn¿t get any product out of the syringe because of a crack was found in the grey stopper of the plunger.The injector didn¿t want to inject the patient with a crack in the syringe because of possible contamination.¿.
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Search Alerts/Recalls
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