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 gas. (Food and Drug Administration)

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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.

Medical Device or Device Component Failure to Unfold or Unwrap

Issue associated with the comprising materials' deformation in that a device fails to open its wrapping or open/extend to a certain fashion…