TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	37	37
Material Separation	34	34
Break	25	25
Fracture	24	24
Detachment of Device or Device Component	19	19
Material Rupture	18	18
Adverse Event Without Identified Device or Use Problem	14	14
Material Split, Cut or Torn	10	10
Difficult to Remove	6	6
Fluid/Blood Leak	4	4
Material Fragmentation	3	3
Crack	3	3
Entrapment of Device	3	3
Nonstandard Device	3	3
Material Deformation	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Fell	3	3
Physical Resistance/Sticking	2	2
Defective Component	2	2
Mechanical Jam	2	2
Defective Device	2	2
Device Contaminated During Manufacture or Shipping	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
Difficult to Insert	1	1
Peeled/Delaminated	1	1
Product Quality Problem	1	1
Restricted Flow rate	1	1
Contamination	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	1
Material Twisted/Bent	1	1
Component Missing	1	1
Structural Problem	1	1
Failure to Advance	1	1
Device Markings/Labelling Problem	1	1
Device Operates Differently Than Expected	1	1
Difficult to Advance	1	1
Packaging Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
No Known Impact Or Consequence To Patient	32	32
No Consequences Or Impact To Patient	32	32
Foreign Body In Patient	31	31
Device Embedded In Tissue or Plaque	25	25
Pneumothorax	14	14
No Code Available	8	8
Insufficient Information	8	8
No Patient Involvement	6	6
Needle Stick/Puncture	3	3
Hernia	2	2
Exposure to Body Fluids	2	2
Hemorrhage/Bleeding	2	2
Hemothorax	2	2
Unspecified Infection	2	2
Liver Laceration(s)	1	1
Phlebitis	1	1
Pleural Effusion	1	1
Pulmonary Edema	1	1
Thrombosis	1	1
Thrombus	1	1
Perforation of Vessels	1	1
Death	1	1
Purulent Discharge	1	1
Pseudoaneurysm	1	1