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	64	64
Misconnection	58	58
Difficult to Open or Close	15	15
Adverse Event Without Identified Device or Use Problem	15	15
Material Twisted/Bent	11	11
Loss of or Failure to Bond	10	10
Break	6	6
Loose or Intermittent Connection	5	5
Defective Component	5	5
Contamination /Decontamination Problem	4	4
Patient-Device Incompatibility	3	3
Therapeutic or Diagnostic Output Failure	2	2
Device Fell	2	2
Material Deformation	2	2
Product Quality Problem	2	2
Difficult to Remove	2	2
Mechanical Problem	2	2
Malposition of Device	2	2
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Defective Device	1	1
Device Tipped Over	1	1
Incorrect Measurement	1	2
Overheating of Device	1	1
Device Difficult to Setup or Prepare	1	2
Contamination	1	1
Fire	1	1
Fluid/Blood Leak	1	1
Material Frayed	1	1
Material Integrity Problem	1	1
Appropriate Term/Code Not Available	1	1
Activation Failure	1	1
Material Split, Cut or Torn	1	1
Sharp Edges	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	152
No Consequences Or Impact To Patient	27	27
Ulcer	9	9
Erythema	4	4
Insufficient Information	4	4
Foreign Body Reaction	3	3
Unspecified Infection	1	1
Skin Inflammation/ Irritation	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Blister	1	1
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1