Catalog Number 96183 |
Device Problems
Crack (1135); Gel Leak (1267)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2019 |
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.These are known potential device malfunctions addressed in the product labeling.
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Event Description
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Healthcare professional reported that during injection with juvéderm volbella® xc, the "luer lock part broke or cracked and the product spilled out".No injury to the patient or injector.The packaged needle was used and was tightened by hand.The syringe is available for return.
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Manufacturer Narrative
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Device analysis: "empty syringe of 1.0 ml filled at 0.55 ml received without plug, no needle in an opened tray & pack.No defect observed to syringe.".
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Event Description
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Healthcare professional reported that during injection with juvéderm volbella® xc, the "luer lock part broke or cracked and the product spilled out." no injury to the patient or injector.The packaged needle was used and was tightened by hand.The syringe is available for return.
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Search Alerts/Recalls
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