| Created: | 1/18/2008 12:22:08 PM |
| Modified: | 2/23/2012 3:23:18 PM |
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DEFINITION:<br /></p><p>The recognition of a product defect that needs to be reported.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>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 /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>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 /></p>
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| Element | Source Role | Target Role |
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Product Class |
Name: involvingPerformedProductProblemDiscovery |
Name: involvedProduct |
 Details:
DESCRIPTION:<br /></p><p>Each PerformedProductProblemDiscovery always focuses on one Product. Each Product might be the focus of one or more PerformedProductProblemDiscovery.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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| Element | Source Role | Target Role |
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SafetyReportVersion Class |
Name: describingSafetyReportVersion |
Name: describedPerformedProductProblemDiscovery |
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Details:
DESCRIPTION:<br /></p><p>Each SafetyReportVersion might describe one or more PerformedProductProblemDiscovery. Each PerformedProductProblemDiscovery might be described by one or more SafetyReportVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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PerformedProductInvestigation Class |
Name: triggeredPerformedProductInvestigation |
Name: triggeringPerformedProductProblemDiscovery |
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DESCRIPTION:<br /></p><p>Each PerformedProductInvestigation always is triggered by one or more PerformedProductProblemDiscovery. Each PerformedProductProblemDiscovery might trigger one or more PerformedProductInvestigation.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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| Tag | Value |
| Map:AE | ProductProblemDiscovery |
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| Map:CTRv1.0 | PerformedProductProblemDiscovery |
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| Map:ICSRr2 | DefectReference (in IndividualCaseSafetyReport) |
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| Object | Type | Connection | Direction | Notes |
| «Comment_Requested» 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): |