TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	434	435
Material Rupture	230	230
Material Puncture/Hole	226	226
Fracture	138	138
Fluid/Blood Leak	109	109
Failure to Deflate	101	101
Adverse Event Without Identified Device or Use Problem	95	95
Leak/Splash	92	92
Difficult to Remove	57	57
Inflation Problem	53	53
Deflation Problem	52	52
Use of Device Problem	42	42
Break	38	39
Detachment of Device or Device Component	35	35
Material Twisted/Bent	23	23
Off-Label Use	20	20
Material Integrity Problem	14	14
Material Fragmentation	11	11
Deformation Due to Compressive Stress	9	9
Improper or Incorrect Procedure or Method	9	9
Difficult to Advance	6	6
Material Deformation	6	6
Loss of or Failure to Bond	5	5
Material Split, Cut or Torn	4	4
Physical Resistance/Sticking	4	4
Failure to Advance	4	5
Mechanical Problem	4	4
Entrapment of Device	4	4
Device-Device Incompatibility	3	3
Unintended Deflation	3	3
Shipping Damage or Problem	3	3
Gas/Air Leak	3	3
Use of Incorrect Control/Treatment Settings	3	3
Contamination	2	2
Accessory Incompatible	2	2
Difficult to Insert	2	2
No Pressure	2	2
Device Damaged by Another Device	2	2
Mechanical Jam	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1
Activation Failure	1	1
Device Contamination with Chemical or Other Material	1	1
Tear, Rip or Hole in Device Packaging	1	1
Product Quality Problem	1	1
Packaging Problem	1	1
Infusion or Flow Problem	1	1
Material Perforation	1	1
Incomplete or Missing Packaging	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1425	1427
Insufficient Information	33	34
No Consequences Or Impact To Patient	19	19
Foreign Body In Patient	15	15
Perforation of Esophagus	9	9
Laceration(s) of Esophagus	7	7
Hemorrhage/Bleeding	7	7
Gastrointestinal Hemorrhage	6	6
Unspecified Tissue Injury	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pancreatitis	2	2
Perforation	2	2
Aspiration/Inhalation	2	2
Pain	2	2
Laceration(s)	2	2
Cough	2	2
Low Oxygen Saturation	2	2
Abdominal Pain	1	1
Unspecified Gastrointestinal Problem	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Embolism/Embolus	1	1
Obstruction/Occlusion	1	1
Needle Stick/Puncture	1	1
Fever	1	1
Vomiting	1	1
Abscess	1	1
Anxiety	1	1
Stenosis	1	1
Fistula	1	1
Device Embedded In Tissue or Plaque	1	1