Catalog Number 93900 |
Device Problems
Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Expulsion (2933)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/26/2018 |
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.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: instructions for use: ¿inject juvéderm® ultra plus xc applying even pressure on the plunger rod while slowly pulling the needle backward.The wrinkle should be lifted and eliminated by the end of the injection.It is important that the injection be stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.¿if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.How supplied: ¿juvéderm® ultra plus xc injectable gel is supplied in individual treatment syringes with 27-g needles for single-patient use and ready for injection (implantation).The volume in each syringe is as stated on the syringe label and on the carton.The contents of the syringe are sterile and non-pyrogenic.Do not resterilize.Do not use if package is opened or damaged.
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Event Description
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Healthcare professional reported one syringe of juvéderm® ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.
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Manufacturer Narrative
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Device analysis: 2 empty syringes of 0.4 ml each received with cap in an opened ultra xc pack.One needle or 2 are stuck in the anti sting cap.No defect observed to both syringes.
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Event Description
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Healthcare professional reported one syringe of juvederm ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.
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Search Alerts/Recalls
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