TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	28	28
Adverse Event Without Identified Device or Use Problem	27	27
Break	24	24
Material Deformation	17	17
Material Too Rigid or Stiff	16	16
Leak/Splash	9	9
Insufficient Information	9	9
Material Puncture/Hole	8	8
Material Integrity Problem	7	7
Disconnection	6	6
Fluid/Blood Leak	4	4
Crack	4	4
Material Split, Cut or Torn	3	3
Device Markings/Labelling Problem	3	3
Detachment of Device or Device Component	3	3
Material Twisted/Bent	3	3
Material Rupture	3	3
Migration or Expulsion of Device	2	2
Physical Resistance/Sticking	2	2
Complete Blockage	2	2
Fracture	2	2
Migration	2	2
Difficult to Remove	2	2
Air/Gas in Device	2	2
Obstruction of Flow	2	2
No Flow	1	1
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Difficult to Open or Close	1	1
Material Too Soft/Flexible	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Material Separation	1	1
Incorrect Measurement	1	1
Structural Problem	1	1
Inaccurate Flow Rate	1	1
Component Missing	1	1
Material Discolored	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Defective Component	1	1
Device Fell	1	1
Difficult to Advance	1	1
Patient-Device Incompatibility	1	1
Restricted Flow rate	1	1
Incomplete or Missing Packaging	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
Insufficient Information	23	23
Foreign Body In Patient	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Infection	11	11
Low Blood Pressure/ Hypotension	10	10
No Information	10	10
Bowel Perforation	10	10
No Known Impact Or Consequence To Patient	10	10
Bradycardia	9	9
Perforation	7	7
Vomiting	7	7
Vaso-Vagal Response	6	6
Pneumothorax	5	5
Hematuria	5	5
Perforation of Esophagus	4	4
Abdominal Distention	4	4
Hypoxia	3	3
Abscess	3	3
Hyperglycemia	3	3
Skin Discoloration	3	3
Electrolyte Imbalance	2	2
Abnormal Blood Gases	2	2
Nausea	2	2
No Consequences Or Impact To Patient	2	2
Hemorrhage/Bleeding	2	2
Internal Organ Perforation	2	2
Apnea	2	2
Lethargy	2	2
Stomach Ulceration	1	1
Laceration(s) of Esophagus	1	1
Pulmonary Emphysema	1	1
Chest Pain	1	1
Pain	1	1
Necrosis	1	1
Laceration(s)	1	1
Choking	1	1
Hypoglycemia	1	1
Unspecified Gastrointestinal Problem	1	1
Gastrointestinal Regurgitation	1	1
Pressure Sores	1	1
Ascites	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1
Distress	1	1