It was reported that the patient deceased intraoperatively during the bha surgery which using corail (p/n: unknown) on (b)(6) 2019.Cardiac insufficiency occurred during closure, and the surgeon performed a cardiac massage however the patient did not reanimate.Doctors comments: it seemed that blood pressure suddenly dropped but the cause was unknown.There was outside a 30 minutes surgical delay.No further information is available.Request for death certificate was performed, though was not available.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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