This concerns a device called the lifevac, manufactured and marketed by: lifevac, llc (b)(4).From this page on the company's website dated yesterday https://bityl.Co/de6w, it was reported to us that on (b)(6) 2022, a 9-year-old boy choked on a lollipop (flat sucker).The candy caused a partial obstruction which turned into a total blockage.Lifevac was used after protocol failed."sucker broke due to the suction of the lifevac and dislodged it into pieces" if the device shattered a lollipop into pieces, that could pose the risk of serious complications.Fda safety report id # (b)(4).
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