TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	69	69
Fluid/Blood Leak	67	67
Migration or Expulsion of Device	50	50
Material Separation	34	34
Loss of or Failure to Bond	33	33
Unraveled Material	29	29
Break	27	27
Detachment of Device or Device Component	26	26
Defective Device	20	20
Crack	13	13
Difficult to Remove	11	11
Adverse Event Without Identified Device or Use Problem	8	8
Unsealed Device Packaging	7	7
Device Contaminated During Manufacture or Shipping	6	6
Material Deformation	5	5
Material Twisted/Bent	5	5
Degraded	5	5
Difficult to Advance	5	5
Physical Resistance/Sticking	4	4
Fracture	4	4
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Material Split, Cut or Torn	3	3
Material Too Rigid or Stiff	2	2
Use of Device Problem	2	2
Gas/Air Leak	2	2
Device-Device Incompatibility	2	2
Difficult to Open or Close	2	2
Disconnection	2	2
Insufficient Information	1	1
Patient-Device Incompatibility	1	1
Material Puncture/Hole	1	1
Device Damaged Prior to Use	1	1
Difficult to Insert	1	1
Stretched	1	1
Peeled/Delaminated	1	1
Program or Algorithm Execution Problem	1	1
Component Missing	1	1
Device Damaged by Another Device	1	1
Entrapment of Device	1	1
Delivered as Unsterile Product	1	1
Separation Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	154	154
No Consequences Or Impact To Patient	78	78
Irritation	50	50
Foreign Body In Patient	28	28
No Known Impact Or Consequence To Patient	26	26
No Patient Involvement	17	17
Insufficient Information	17	17
Awareness during Anaesthesia	7	7
Low Blood Pressure/ Hypotension	6	6
Hemorrhage/Bleeding	4	4
Device Embedded In Tissue or Plaque	4	4
Unspecified Infection	2	2
Failure of Implant	2	2
No Code Available	2	2
Skin Inflammation/ Irritation	2	2
Seroma	2	2
Discomfort	2	2
Laceration(s)	2	2
Pain	2	2
Perforation of Vessels	2	2
Inadequate Pain Relief	2	2
Low Oxygen Saturation	2	2
Air Embolism	1	1
High Blood Pressure/ Hypertension	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
No Information	1	1
Blood Loss	1	1
Blister	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Dyspnea	1	1
Coma	1	1
Tachycardia	1	1
Cough	1	1
Swelling/ Edema	1	1
Hyperventilation	1	1
Great Vessel Perforation	1	1
Pseudoaneurysm	1	1
Internal Organ Perforation	1	1