" /> Performed Product Problem Discovery - CISMeF





Preferred Label : Performed Product Problem Discovery;

NCIt related terms : PerformedProductProblemDiscovery;

NCIt definition : The completed activity for determining issues associated with products. May be based on FDA CDRH Conclusion Codes.;

Alternative definition : BRIDG 3.0.3: Based on FDA CDRH Conclusion Codes. EXAMPLE(S): 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).;

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12/05/2024


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