TPLC - Total Product Life Cycle

show TPLC since

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
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
Difficult to Open or Close	2	2
Use of Device Problem	2	2
Material Too Rigid or Stiff	2	2
Gas/Air Leak	2	2
Disconnection	2	2
Device-Device Incompatibility	2	2
Device Dislodged or Dislocated	1	1
Delivered as Unsterile Product	1	1
Device Damaged by Another Device	1	1
Component Missing	1	1
Activation, Positioning or Separation Problem	1	1
Separation Problem	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Tear, Rip or Hole in Device Packaging	1	1
Stretched	1	1
Difficult to Insert	1	1
Program or Algorithm Execution Problem	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Device Damaged Prior to Use	1	1
Peeled/Delaminated	1	1
Entrapment of Device	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
No Code Available	2	2
Failure of Implant	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
Pseudoaneurysm	1	1
Great Vessel Perforation	1	1
Hyperventilation	1	1
Internal Organ Perforation	1	1