Medical Device Packaging Issue

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

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

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

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

Issue associated with mechanical force that displaces device and/or device components from an intended location.

Issue associated with one device and/or device component causing harm to another device and/or component.