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	29	29
Break	26	26
Unraveled Material	25	25
Detachment of Device or Device Component	25	25
Defective Device	20	20
Crack	13	13
Difficult to Remove	10	10
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
Difficult to Advance	5	5
Degraded	5	5
Material Twisted/Bent	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
Device-Device Incompatibility	2	2
Disconnection	2	2
Material Too Rigid or Stiff	2	2
Use of Device Problem	2	2
Device Damaged Prior to Use	1	1
Component Missing	1	1
Tear, Rip or Hole in Device Packaging	1	1
Peeled/Delaminated	1	1
Material Puncture/Hole	1	1
Entrapment of Device	1	1
Difficult to Insert	1	1
Delivered as Unsterile Product	1	1
Activation, Positioning or Separation Problem	1	1
Device Damaged by Another Device	1	1
Patient-Device Incompatibility	1	1
Stretched	1	1
Device Dislodged or Dislocated	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Migration	1	1
Program or Algorithm Execution Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	145	145
No Consequences Or Impact To Patient	78	78
Irritation	50	50
Foreign Body In Patient	26	26
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
No Code Available	2	2
Low Oxygen Saturation	2	2
Discomfort	2	2
Inadequate Pain Relief	2	2
Failure of Implant	2	2
Unspecified Infection	2	2
Laceration(s)	2	2
Seroma	2	2
Perforation of Vessels	2	2
Great Vessel Perforation	1	1
Tachycardia	1	1
Ventricular Fibrillation	1	1
Internal Organ Perforation	1	1
Pain	1	1
Cardiac Arrest	1	1
Dyspnea	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Hyperventilation	1	1
Coma	1	1
Blood Loss	1	1
Pseudoaneurysm	1	1
Air Embolism	1	1
Cough	1	1
Respiratory Arrest	1	1
Blister	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
No Information	1	1