TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	32	32
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
Device Fell	3	3
Crack	3	3
Tear, Rip or Hole in Device Packaging	3	3
Fluid/Blood Leak	3	3
Nonstandard Device	3	3
Device Contaminated During Manufacture or Shipping	2	2
Entrapment of Device	2	2
Defective Device	2	2
Defective Component	2	2
Mechanical Jam	2	2
Use of Device Problem	2	2
Material Deformation	2	2
Dull, Blunt	1	1
Suction Problem	1	1
Physical Resistance/Sticking	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination	1	1
Appropriate Term/Code Not Available	1	1
Failure to Advance	1	1
Structural Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Product Quality Problem	1	1
Unraveled Material	1	1
Restricted Flow rate	1	1
Device Markings/Labelling Problem	1	1
Peeled/Delaminated	1	1
Material Fragmentation	1	1
Difficult to Advance	1	1
Material Twisted/Bent	1	1
Component Missing	1	1
Difficult to Insert	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	39
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
Hemorrhage/Bleeding	3	3
Hernia	2	2
Hemothorax	2	2
Unspecified Infection	1	1
Death	1	1
Exposure to Body Fluids	1	1
Pleural Effusion	1	1
Perforation of Vessels	1	1
Pulmonary Edema	1	1
Pseudoaneurysm	1	1
Liver Laceration(s)	1	1