Health / Medical Topics |
Medical Device Misassembled by Users
Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents. (Food and Drug Administration)
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Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.
Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material
Issue associated with a partial or full-thickness crack in the device materials.
Issue associated with an undesired disassociation or breaking apart of device materials.
Issue associated with the bursting or tearing apart of a material.
Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object.