This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
: FDA Additional Seriousness Criteria CodeSystem - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:CodeSystem ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "fda-add-seriousness-criteria-cs"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs</code> defines the following code:</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\">requiresPreventImpairment<a name=\"fda-add-seriousness-criteria-cs-requiresPreventImpairment\"> </a></td><td>Required Intervention to Prevent Permanent Impairment or Damage (Devices)</td><td>Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product</td></tr></table></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
fhir:v "informative" ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig> ] ] ) ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs"^^xsd:anyURI] ; #
fhir:version [ fhir:v "1.0.0-ballot"] ; #
fhir:name [ fhir:v "FDAaddSeriousnessCriteriaCS"] ; #
fhir:title [ fhir:v "FDA Additional Seriousness Criteria CodeSystem"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:experimental [ fhir:v "true"^^xsd:boolean] ; #
fhir:date [ fhir:v "2023-07-28T19:53:38+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups"] ; #
fhir:contact ( [
fhir:name [ fhir:v "Biomedical Research and Regulation WG" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://hl7.org/Special/committees/rcrim" ] ] )
] ) ; #
fhir:description [ fhir:v "Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch)."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
fhir:code [ fhir:v "001" ] ] )
] ) ; #
fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; #
fhir:content [ fhir:v "complete"] ; #
fhir:count [ fhir:v "1"^^xsd:nonNegativeInteger] ; #
fhir:concept ( [
fhir:code [ fhir:v "requiresPreventImpairment" ] ;
fhir:display [ fhir:v "Required Intervention to Prevent Permanent Impairment or Damage (Devices)" ] ;
fhir:definition [ fhir:v "Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product" ]
] ) . #
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