Category of Adverse Events in Smart Bear - JSON Representation

Smart Bear Implementation Guide
0.3.4 - ci-build
Smart Bear Implementation Guide - Local Development build (v0.3.4). See the Directory of published versions
: Category of Adverse Events in Smart Bear - JSON Representation

Active as of 2024-04-22

{
  "resourceType" : "CodeSystem",
  "id" : "CategoryAdverseEventCS",
  "text" : {
    "status" : "generated",
    "div" : "<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>"
  },
  "url" : "https://smart-bear.eu/fhir/CodeSystem/CategoryAdverseEventCS",
  "version" : "0.3.4",
  "name" : "CategoryAdverseEventCS",
  "title" : "Category of Adverse Events in Smart Bear",
  "status" : "active",
  "date" : "2024-04-22T12:34:38+02:00",
  "description" : "Category codes for adverse events in Smart Bear",
  "content" : "complete",
  "count" : 6,
  "concept" : [
    {
      "code" : "Adverse_Event",
      "display" : "Adverse Event (AE)",
      "definition" : "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"
    },
    {
      "code" : "Adverse_Device_Effect",
      "display" : "Adverse Device Effect (ADE)"
    },
    {
      "code" : "Serious_Adverse_Event",
      "display" : "Serious Adverse Event (SAE)"
    },
    {
      "code" : "Serious_Adverse_Device_Effect",
      "display" : "Serious Adverse Device Effect (SADE)"
    },
    {
      "code" : "Unanticipated_Serious_Adverse_Device_Effect",
      "display" : "Unanticipated Serious Adverse Device Effect (USADE)"
    },
    {
      "code" : "Device_Deficiency",
      "display" : "Device Deficiency (DD)"
    }
  ]
}