TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	304	304
Break	241	241
Product Quality Problem	92	92
Material Fragmentation	73	73
Material Separation	26	26
Detachment Of Device Component	22	22
Device Slipped	21	21
Improper or Incorrect Procedure or Method	17	17
Device Fell	15	15
Adverse Event Without Identified Device or Use Problem	14	14
Component Falling	11	11
Entrapment of Device	9	9
Material Disintegration	7	7
Defective Device	5	5
Patient-Device Incompatibility	5	5
Physical Resistance/Sticking	5	5
Material Twisted/Bent	4	4
Loose or Intermittent Connection	4	4
Difficult to Remove	3	3
Device Contamination with Chemical or Other Material	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Integrity Problem	3	3
Material Protrusion/Extrusion	2	2
Device Dislodged or Dislocated	2	2
Material Too Rigid or Stiff	2	2
Fluid/Blood Leak	2	2
Insufficient Information	2	2
Patient Device Interaction Problem	2	2
Naturally Worn	1	1
Unintended Electrical Shock	1	1
Device Damaged Prior to Use	1	1
Out-Of-Box Failure	1	1
Structural Problem	1	1
Mechanical Problem	1	1
Peeled/Delaminated	1	1
Bent	1	1
Device Operates Differently Than Expected	1	1
Contamination /Decontamination Problem	1	1
Sticking	1	1
Inadequate User Interface	1	1
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	221	221
No Known Impact Or Consequence To Patient	183	183
No Clinical Signs, Symptoms or Conditions	107	107
Foreign Body In Patient	84	84
Choking	47	47
Device Embedded In Tissue or Plaque	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
No Code Available	22	22
Pain	13	13
No Information	10	10
Cough	9	9
Discomfort	7	7
Laceration(s)	7	7
Swelling	7	7
Vomiting	7	7
No Consequences Or Impact To Patient	5	5
Injury	4	4
Hemorrhage/Bleeding	4	4
Hypersensitivity/Allergic reaction	4	4
Reaction	4	4
Sensitivity of Teeth	3	3
No Patient Involvement	3	3
Unspecified Tissue Injury	3	3
Dyspnea	3	3
Emotional Changes	2	2
Abscess	2	2
Unspecified Infection	2	2
Anxiety	2	2
Burning Sensation	2	2
Unspecified Gastrointestinal Problem	2	2
Tooth Fracture	2	2
Needle Stick/Puncture	2	2
Numbness	2	2
Complaint, Ill-Defined	2	2
Collapse	1	1
Post Traumatic Wound Infection	1	1
Hypervolemia	1	1
Dysuria	1	1
Chemical Exposure	1	1
Patient Problem/Medical Problem	1	1
Stomatitis	1	1
Tingling	1	1
Malaise	1	1
Depression	1	1
Sore Throat	1	1
Tachycardia	1	1
Thrombosis	1	1
Thrombus	1	1
Tissue Damage	1	1
Ulceration	1	1
Rash	1	1
Skin Discoloration	1	1
Suffocation	1	1
Inflammation	1	1
Irritation	1	1
Itching Sensation	1	1
Hemorrhage, Cerebral	1	1
Vessel Or Plaque, Device Embedded In	1	1
Abrasion	1	1
Airway Obstruction	1	1
Asthma	1	1
Burn(s)	1	1
Eye Injury	1	1
Hemoptysis	1	1