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	66	66
Migration or Expulsion of Device	50	50
Loss of or Failure to Bond	33	33
Material Separation	30	30
Break	27	27
Detachment of Device or Device Component	26	26
Unraveled Material	25	25
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
Degraded	5	5
Difficult to Advance	5	5
Material Twisted/Bent	5	5
Fracture	4	4
Physical Resistance/Sticking	4	4
Material Split, Cut or Torn	3	3
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Difficult to Open or Close	2	2
Gas/Air Leak	2	2
Use of Device Problem	2	2
Material Too Rigid or Stiff	2	2
Device-Device Incompatibility	2	2
Disconnection	2	2
Component Missing	1	1
Entrapment of Device	1	1
Program or Algorithm Execution Problem	1	1
Peeled/Delaminated	1	1
Difficult to Insert	1	1
Device Damaged Prior to Use	1	1
Insufficient Information	1	1
Patient-Device Incompatibility	1	1
Stretched	1	1
Material Puncture/Hole	1	1
Activation, Positioning or Separation Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Separation Problem	1	1
Delivered as Unsterile Product	1	1
Migration	1	1
No Apparent Adverse Event	1	1
Device Damaged by Another Device	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	147	147
No Consequences Or Impact To Patient	78	78
Irritation	50	50
Foreign Body In Patient	27	27
No Known Impact Or Consequence To Patient	26	26
No Patient Involvement	17	17
Insufficient Information	16	16
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