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 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: 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 (hcp) reported that upon injection of juvéderm® volbella¿ with lidocaine, product "[fell] on the patient]".Hcp observed a "tiny hole, breakage" in the luer lock area of the syringe.Hcp also observed "solidity of the product not due to the needle or loss of the product".No patient injury reported.
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