Post Market Surveillance & Adverse Event Reporting What is an

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Post Market Surveillance & AdverseEvent ReportingWhat is an Adverse Event : (USA)An adverse event is any undesirable experience associated withthe use of a medical product in a patient.Serious Adverse Event:The adverse event is serious and should be reported to FDA whenthe patient outcome is:• Death• Life-threatening• Hospitalization (initial or prolonged)• Disability or Permanent Damage• Congenital Anomaly/Birth Defect• Required Intervention to Prevent Permanent Impairment or Damage• Other Serious (Important Medical Events)http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm
Post Market Surveillance & AdverseEvent ReportingWhat is an Adverse Event : (EU)INCIDENT (= Adverse Event in the context of this overview)“Any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in the labelingor the instructions for use which, directly or indirectly, might leadto or might have led to the death of a patient, or user or of otherpersons or to a serious deterioration in their state of health.”Source: MEDDEV 2.12http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf
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Post Market Surveillance & Adverse Event Reporting What is an

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