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PATIENT CARE ADVERSE AND SENTINEL EVENTSHOSPITAL NAME: ___ Date created or updated: ___AHA Standard Referenced: PC57. The practice has a written protocol that defines what constitutes an adverse/
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A serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
Healthcare professionals, manufacturers, and consumers are required to file reports of serious adverse events to the FDA.
The FDA provides specific forms and guidelines for reporting serious adverse events. These forms must be filled out accurately and submitted within the specified timeframe.
The purpose of reporting serious adverse events is to monitor the safety of medical products, identify potential risks, and take appropriate actions to protect public health.
Information such as patient demographics, details of the adverse event, medical interventions, outcomes, and any relevant medical history must be reported on a serious adverse event report.
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