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 18 patients using a revaclear 400 experienced chills, headache, malaise and nausea during therapy.The patients were treated with 100mg of hydrocortisone intravenously, 75mg of diclofenac, 3lt x1mts of oxygen and 1g of vancomycin was administered intravenously.It was reported that the patients improved after treatment.No additional information is available.
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