Performed Product Problem Discovery

Definition 1

Based on FDA CDRH Conclusion Codes. (NCI Thesaurus)

Definition 2

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). (NCI Thesaurus/BRIDG)

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Performed Product Investigation Result Evaluation Conclusion Code

A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. …

Performed Product Investigation Result Device Malfunction Code

A coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is…

Performed Product Investigation Result Defect Type Code

A coded value specifying the kind of device-related events that characterize the reported event/problem.

Performed Product Investigation Result Conclusion

A text or otherwise formatted description of the final results drawn from the investigation.

Performed Product Investigation Result

Information captured while conducting research on a product.

Performed Product Investigation

The completed process of evaluating a product after it has been returned to the manufacturer or reprocessor.