TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	71	71
Break	53	53
Detachment of Device or Device Component	24	24
Retraction Problem	17	17
Difficult to Open or Close	13	13
Material Twisted/Bent	11	11
Mechanical Problem	7	7
Entrapment of Device	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Insufficient Information	5	5
Activation Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Device Contaminated During Manufacture or Shipping	2	2
Activation Failure	2	2
Material Puncture/Hole	2	2
Difficult to Remove	2	2
Material Fragmentation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Activation, Positioning or Separation Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Dislodged or Dislocated	1	1
Material Separation	1	1
Use of Device Problem	1	1
Fracture	1	1
Unsealed Device Packaging	1	1
Separation Problem	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Unintended Movement	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Material Protrusion/Extrusion	1	1
Human-Device Interface Problem	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
No Consequences Or Impact To Patient	43	43
No Known Impact Or Consequence To Patient	18	18
Insufficient Information	13	13
Hemorrhage/Bleeding	6	6
Hematoma	3	3
Perforation	2	2
Foreign Body In Patient	2	2
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1
Anxiety	1	1
Discomfort	1	1
Bacterial Infection	1	1
Laceration(s)	1	1