This patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in oldham, united kingdom.Through review of the final clinical study adverse event listings, it was reported that a patient experienced melena.As no further notification was received regarding this adverse event, no further information is available.No capa was opened because of this event.Bleeding is a known potential complication that can occur during extracorporeal therapy.Alung technologies, inc will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.Complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.
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