Phone number: (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 a patient experienced severe abdominal pain within 40 minutes of treatment using a polyflux 140h and had to go to the bathroom.Upon returning from using the toilet, treatment was restarted and the patient experienced a sudden respiratory and cardiac arrest and loss of consciousness.The patient was given cardiac electrical defibrillation, intubation ventilator to assist breathing and other unspecified measures.After the recovery of respiration and heartbeat, the patient was sent to intensive care unit and continued to be in a coma.No additional information is available.
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