Medical Device Evaluation Methods Terminology FDA CDRH

Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events.

Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. …

Device and/or fragments of device are embedded in patient's vessel and/or plaque.

Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with…

Issue associated with a failure of the electrical circuitry or components of the device.

Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if…