Device Platelet Activation Problem Evaluation Result

A device that affects the body's ability to activate platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events. (Food and Drug Administration)

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Device Physical Structure Testing Evaluation Method

Testing the device for problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.

Device Pathological Examination Evaluation Method

Examining material that may have contributed to the disease or damage. Often performed using a microscope by measuring structural changes that occur…

Device Parameters

Technical specifications about a device that are issued by the manufacturer.

Device Packaging Verification Evaluation Method

Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable…

Device Packaging Problem Evaluation Result

Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents). …

Device Packaging Compromised Evaluation Result Evaluation Result

Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or…