Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: precautions: juvéderm® ultra plus xc is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.Juvéderm® ultra plus xc 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.After use, treatment syringes and needles may be potential biohazards.Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.Juvéderm® ultra plus xc injectable gel is a clear, colorless gel without visible particulates.In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify allergan product support at 1-877-345-5372.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: 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.
|