: Public Class
Created: 1/18/2008 12:22:08 PM
Modified: 8/26/2017 1:19:11 AM
Project:
Advanced:
DEFINITION:<br/>The recognition of a product defect that needs to be reported.<br/><br/>EXAMPLE(S):<br/>An imaging device is discovered to be leaking radiation. This was discovered on Jan. 10th, but it suspected to have been leaking for a week.  This element maps to the ProductDefectDiscovery class in ICSR and maps to the MedWatch Form 3500A section B1 (Product problem checkbox).<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every PerformedProductProblemDiscovery be described by a SafetyReportVersion.<br/>
Element Source Role Target Role
Product
Class  
Name: involvingPerformedProductProblemDiscovery
 
Name: involvedProduct
 
Details:
DESCRIPTION:<br/>Each PerformedProductProblemDiscovery always focuses on one Product. Each Product might be the focus of one or more PerformedProductProblemDiscovery.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
SafetyReportVersion
Class  
Name: describingSafetyReportVersion
 
Name: describedPerformedProductProblemDiscovery
 
Details:
DESCRIPTION:<br/>Each SafetyReportVersion might describe one or more PerformedProductProblemDiscovery.  Each PerformedProductProblemDiscovery might be described by one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedProductInvestigation
Class  
Name: triggeredPerformedProductInvestigation
 
Name: triggeringPerformedProductProblemDiscovery
 
Details:
DESCRIPTION:<br/>Each PerformedProductInvestigation always is triggered by one or more PerformedProductProblemDiscovery. Each PerformedProductProblemDiscovery might trigger one or more PerformedProductInvestigation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:AE ProductProblemDiscovery
Details:
 
Map:CTRv1.0 PerformedProductProblemDiscovery
Details:
 
Map:ICSRr2 DefectReference (in IndividualCaseSafetyReport)
Details:
 
Object Type Connection Direction Notes
PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedProductProblemDiscovery always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedProductProblemDiscovery. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):