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 during treatment with a revaclear 400 dialyzer, the patient experienced an allergic reaction manifested as tremors, rash, cough, chest pain, itchy throat and dyspnea.The patient was treated with hydrocortisone, a nebulizer (nbz ) and o2 through a nasal catheter.No additional information is available.
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