TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	31	31
Leak/Splash	29	29
Fracture	22	22
Break	20	20
Material Rupture	18	18
Detachment of Device or Device Component	18	18
Adverse Event Without Identified Device or Use Problem	12	12
Material Split, Cut or Torn	9	9
Difficult to Remove	5	5
Fluid/Blood Leak	3	3
Crack	3	3
Nonstandard Device	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Fell	3	3
Mechanical Jam	2	2
Defective Component	2	2
Defective Device	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Entrapment of Device	2	2
Use of Device Problem	2	2
Suction Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Unraveled Material	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Restricted Flow rate	1	1
Contamination	1	1
Peeled/Delaminated	1	1
Product Quality Problem	1	1
Material Twisted/Bent	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Physical Resistance/Sticking	1	1
Packaging Problem	1	1
Appropriate Term/Code Not Available	1	1
Device Markings/Labelling Problem	1	1
Difficult to Advance	1	1
Component Missing	1	1
Structural Problem	1	1
Failure to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	38	38
No Known Impact Or Consequence To Patient	29	29
No Consequences Or Impact To Patient	27	27
Device Embedded In Tissue or Plaque	26	26
Foreign Body In Patient	23	23
Pneumothorax	9	9
Insufficient Information	8	8
No Code Available	7	7
No Patient Involvement	6	6
Needle Stick/Puncture	3	3
Hernia	2	2
Hemorrhage/Bleeding	2	2
Hemothorax	2	2
Unspecified Infection	1	1
Liver Laceration(s)	1	1
Pleural Effusion	1	1
Pulmonary Edema	1	1
Perforation of Vessels	1	1
Exposure to Body Fluids	1	1
Death	1	1
Pseudoaneurysm	1	1