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: precautions: ¿failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.Instructions for use: ¿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 xc injectable gel is supplied in individual treatment syringes with 30 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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