Category of Adverse Events in Smart Bear - XML Representation - Smart Bear Implementation Guide v0.3.4

Smart Bear Implementation Guide
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: Category of Adverse Events in Smart Bear - XML Representation

Active as of 2024-04-22


<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="CategoryAdverseEventCS"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This code system <code>https://smart-bear.eu/fhir/CodeSystem/CategoryAdverseEventCS</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">Adverse_Event<a name="CategoryAdverseEventCS-Adverse_Event"> </a></td><td>Adverse Event (AE)</td><td>Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device</td></tr><tr><td style="white-space:nowrap">Adverse_Device_Effect<a name="CategoryAdverseEventCS-Adverse_Device_Effect"> </a></td><td>Adverse Device Effect (ADE)</td><td/></tr><tr><td style="white-space:nowrap">Serious_Adverse_Event<a name="CategoryAdverseEventCS-Serious_Adverse_Event"> </a></td><td>Serious Adverse Event (SAE)</td><td/></tr><tr><td style="white-space:nowrap">Serious_Adverse_Device_Effect<a name="CategoryAdverseEventCS-Serious_Adverse_Device_Effect"> </a></td><td>Serious Adverse Device Effect (SADE)</td><td/></tr><tr><td style="white-space:nowrap">Unanticipated_Serious_Adverse_Device_Effect<a name="CategoryAdverseEventCS-Unanticipated_Serious_Adverse_Device_Effect"> </a></td><td>Unanticipated Serious Adverse Device Effect (USADE)</td><td/></tr><tr><td style="white-space:nowrap">Device_Deficiency<a name="CategoryAdverseEventCS-Device_Deficiency"> </a></td><td>Device Deficiency (DD)</td><td/></tr></table></div>
  </text>
  <url value="https://smart-bear.eu/fhir/CodeSystem/CategoryAdverseEventCS"/>
  <version value="0.3.4"/>
  <name value="CategoryAdverseEventCS"/>
  <title value="Category of Adverse Events in Smart Bear"/>
  <status value="active"/>
  <date value="2024-04-22T12:34:38+02:00"/>
  <description value="Category codes for adverse events in Smart Bear"/>
  <content value="complete"/>
  <count value="6"/>
  <concept>
    <code value="Adverse_Event"/>
    <display value="Adverse Event (AE)"/>
    <definition
                value="Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device"/>
  </concept>
  <concept>
    <code value="Adverse_Device_Effect"/>
    <display value="Adverse Device Effect (ADE)"/>
  </concept>
  <concept>
    <code value="Serious_Adverse_Event"/>
    <display value="Serious Adverse Event (SAE)"/>
  </concept>
  <concept>
    <code value="Serious_Adverse_Device_Effect"/>
    <display value="Serious Adverse Device Effect (SADE)"/>
  </concept>
  <concept>
    <code value="Unanticipated_Serious_Adverse_Device_Effect"/>
    <display value="Unanticipated Serious Adverse Device Effect (USADE)"/>
  </concept>
  <concept>
    <code value="Device_Deficiency"/>
    <display value="Device Deficiency (DD)"/>
  </concept>
</CodeSystem>