Medical Device Problem Codes FDA CDRH

Terminology used for defining mode of medical device failure or malfunction in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post approval periods of medical device development and usage. (NCI Thesaurus)

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Medical Device Pressure Issue

Issue associated with the application of a force either internal or external to the device that compromises the flow of fluid or…

Medical Device Position Issue

Issue associated with the movement of the device and/or device components to an intended location.

Medical Device Packaging Issue

Issue associated with the materials used to construct the cover or outer wrapping of the device.

Medical Device Output Issue

Issue associated with any deviation from device documented performance specifications relating to the end result, data, or test results provided by the…

Medical Device or Device Fragments Remain in Patient

Issue associated with the inability to retrieve device and/or device fragments during medical procedures.

Medical Device or Device Component Quality Issue

Issue associated with an inherent device and/or device component characteristic that is not satisfactory as specified or delivered.