Further information from the reporter regarding event details has been requested.No additional information is available at this time.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 labeling addresses the reported event(s) as follows: method of use - posology ¿ juvéderm® volift¿ with lidocaine is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.¿ remove tip cap by pulling it straight off the syringe.Then firmly push the needle provided in the box into the syringe, screwing it gently clockwise.Twist once more until it is fully locked.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, and pulling the two hands in opposite directions.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.
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Healthcare professional reported that while injecting juvéderm® volift¿ with lidocaine in the nasolabial folds, "the needle got displaced," and "product popped out of syringe while injecting." "most of the product came out on the skin." no impact to patient or medical staff.
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Healthcare professional reported that while injecting juvederm volift with lidocaine in the nasolabial folds, "the needle got displaced," and "product popped out of syringe while injecting." "most of the product came out on the skin." no impact to patient or medical staff.
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