A hemodialysis patient experienced a rash which occurred following treatment after using a xenium dialyzer.The patient was treated with loratadine (dose, route, frequency and duration not reported).The filter was changed, therapy end regularly and the patient was discharged.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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