TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	510	510
Material Rupture	438	438
Material Puncture/Hole	280	280
Fluid/Blood Leak	153	153
Fracture	137	137
Deflation Problem	94	94
Adverse Event Without Identified Device or Use Problem	73	73
Failure to Deflate	66	66
Leak/Splash	65	65
Break	50	50
Use of Device Problem	49	49
Detachment of Device or Device Component	48	48
Difficult to Remove	46	46
Inflation Problem	43	43
Material Twisted/Bent	39	39
Crack	25	25
Off-Label Use	24	24
Improper or Incorrect Procedure or Method	15	15
Material Fragmentation	15	15
Material Integrity Problem	15	15
Material Deformation	14	14
Appropriate Term/Code Not Available	8	8
Device-Device Incompatibility	7	7
Physical Resistance/Sticking	7	7
Deformation Due to Compressive Stress	6	6
Difficult to Advance	6	6
Retraction Problem	6	6
Failure to Advance	5	5
Material Split, Cut or Torn	4	4
Entrapment of Device	4	4
Mechanical Problem	4	4
Loss of or Failure to Bond	3	3
Defective Device	3	3
Difficult to Insert	3	3
Shipping Damage or Problem	3	3
Gas/Air Leak	3	3
Device Contamination with Chemical or Other Material	3	3
Failure to Eject	3	3
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Packaging Problem	3	3
Contamination	2	2
No Pressure	2	2
Accessory Incompatible	2	2
Use of Incorrect Control/Treatment Settings	2	2
Activation, Positioning or Separation Problem	1	1
Mechanical Jam	1	1
Device Contaminated During Manufacture or Shipping	1	1
Human-Device Interface Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1112	1112
No Consequences Or Impact To Patient	646	646
No Known Impact Or Consequence To Patient	69	69
Insufficient Information	26	26
No Patient Involvement	20	20
Foreign Body In Patient	19	19
Perforation of Esophagus	14	14
Perforation	12	12
Laceration(s) of Esophagus	10	10
Hemorrhage/Bleeding	9	9
Device Embedded In Tissue or Plaque	9	9
Gastrointestinal Hemorrhage	6	6
Chest Pain	4	4
Laceration(s)	4	4
Death	3	3
Aspiration/Inhalation	3	3
Unspecified Tissue Injury	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pancreatitis	2	2
No Code Available	2	2
Cough	2	2
Low Oxygen Saturation	2	2
Abdominal Pain	1	1
Patient Problem/Medical Problem	1	1
Unspecified Gastrointestinal Problem	1	1
Inflammation	1	1
Obstruction/Occlusion	1	1
Fever	1	1
Injury	1	1
Needle Stick/Puncture	1	1
Nerve Damage	1	1
Vomiting	1	1
Hemostasis	1	1
Pain	1	1
Abscess	1	1
Anxiety	1	1
Tissue Damage	1	1
Fistula	1	1