It was reported that within 20 minutes of starting treatment with polyflux 14l, the patient experienced abdominal pain and sweat.Treatment was stopped immediately, and the patient received a dexamethasone intravenous infusion of 10 mg for the events.It was reported the patient¿s symptoms were relieved 15 minutes later and treatment was continued.It was further reported the "patient is stable now".No additional information is available.
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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