Health / Medical Topics

Medical Device Expiration Date Error

Issue associated with errors in identification of expiration date. (Food and Drug Administration)

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Medical Device Evaluation Results Terminology FDA CDRH

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

Medical Device Evaluation Methods Terminology FDA CDRH

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

Medical Device Evaluation Conclusions Terminology FDA CDRH

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

Medical Device Emits Smoke

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

Medical Device Embedded In Vessel Or Plaque

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

Medical Device Electronic Property Issue

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

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