TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	65	65
Fluid/Blood Leak	64	64
Migration or Expulsion of Device	50	50
Loss of or Failure to Bond	33	33
Material Separation	28	28
Detachment of Device or Device Component	25	25
Unraveled Material	24	24
Break	21	21
Defective Device	20	20
Crack	13	13
Difficult to Remove	10	10
Adverse Event Without Identified Device or Use Problem	8	8
Device Contaminated During Manufacture or Shipping	6	6
Unsealed Device Packaging	6	6
Degraded	5	5
Material Deformation	5	5
Material Twisted/Bent	5	5
Physical Resistance/Sticking	4	4
Difficult to Advance	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	136	136
No Consequences Or Impact To Patient	78	78
Irritation	50	50
No Known Impact Or Consequence To Patient	26	26
Foreign Body In Patient	23	23
No Patient Involvement	17	17
Insufficient Information	14	14
Awareness during Anaesthesia	7	7
Low Blood Pressure/ Hypotension	6	6
Device Embedded In Tissue or Plaque	4	4
Hemorrhage/Bleeding	3	3
Failure of Implant	2	2
Unspecified Infection	2	2
Laceration(s)	2	2
Seroma	2	2
Perforation of Vessels	2	2
No Code Available	2	2
Low Oxygen Saturation	2	2
Discomfort	2	2
Inadequate Pain Relief	2	2
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
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