TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	109	109
Misconnection	68	68
Loss of or Failure to Bond	36	36
Adverse Event Without Identified Device or Use Problem	17	17
Disconnection	16	16
Difficult to Open or Close	16	16
Material Twisted/Bent	15	15
Break	9	9
Malposition of Device	8	8
Loose or Intermittent Connection	7	7
Contamination /Decontamination Problem	7	7
Defective Component	6	6
Material Separation	4	4
Product Quality Problem	4	4
Mechanical Problem	3	3
Patient-Device Incompatibility	3	3
Difficult to Remove	3	3
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Degraded	2	2
Material Deformation	2	2
Fluid/Blood Leak	1	1
Improper or Incorrect Procedure or Method	1	1
Connection Problem	1	1
Appropriate Term/Code Not Available	1	1
Activation Failure	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination of Device Ingredient or Reagent	1	1
Incorrect Measurement	1	1
Sharp Edges	1	1
Infusion or Flow Problem	1	1
Component Missing	1	1
Device Difficult to Setup or Prepare	1	1
Inadequate Instructions for Healthcare Professional	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Unsealed Device Packaging	1	1
Device Fell	1	1
Physical Resistance/Sticking	1	1
Device Tipped Over	1	1
Fire	1	1
Material Split, Cut or Torn	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	163	163
No Consequences Or Impact To Patient	118	118
Ulcer	9	9
No Patient Involvement	8	8
Insufficient Information	6	6
Erythema	4	4
Foreign Body Reaction	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1
Death	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Purulent Discharge	1	1
Itching Sensation	1	1
Blister	1	1
Foreign Body In Patient	1	1
Reaction	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1