Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

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

CodeSystem: FDA Additional Seriousness Criteria CodeSystem (Experimental)

Official URL: http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs Version: 1.0.0-ballot
Standards status: Informative Computable Name: FDAaddSeriousnessCriteriaCS

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).

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This code system http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs defines the following code:

CodeDisplayDefinition
requiresPreventImpairment Required Intervention to Prevent Permanent Impairment or Damage (Devices)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