The patient was born on an unspecified date in (b)(6).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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It was reported that 12 hours after treatment ended with a theranova 500 dialyzer, the patient experienced angioedema, left hemi-language edema, mucosal edema, buccal edema, and dyspnea.The patient presented to the emergency department and was treated with intravenous urbason and polaramine.It was reported the symptoms ¿disappeared¿ and the patient was recovered from the events.At the time of this report, the patient receives treatment with a non-baxter dialyzer.No additional information is available.
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