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	313	313
Break	225	225
Product Quality Problem	107	107
Material Fragmentation	68	68
Material Separation	24	24
Device Slipped	21	21
Adverse Event Without Identified Device or Use Problem	17	17
Improper or Incorrect Procedure or Method	16	16
Device Fell	13	13
Defective Device	7	7
Physical Resistance/Sticking	5	5
Material Disintegration	5	5
Material Twisted/Bent	4	4
Patient-Device Incompatibility	4	4
Insufficient Information	4	4
Entrapment of Device	4	4
Loose or Intermittent Connection	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Patient Device Interaction Problem	2	2
Difficult to Remove	2	2
No Apparent Adverse Event	2	2
Device Dislodged or Dislocated	1	1
Contamination /Decontamination Problem	1	1
Unintended Electrical Shock	1	1
Material Integrity Problem	1	1
Material Protrusion/Extrusion	1	1
Protective Measures Problem	1	1
Material Too Rigid or Stiff	1	1
Peeled/Delaminated	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Contamination with Chemical or Other Material	1	1
Packaging Problem	1	1
Inadequate User Interface	1	1
Fluid/Blood Leak	1	1
Mechanical Problem	1	1
Naturally Worn	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	221	221
No Clinical Signs, Symptoms or Conditions	175	175
No Known Impact Or Consequence To Patient	123	123
Foreign Body In Patient	65	65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
Device Embedded In Tissue or Plaque	46	46
Choking	42	42
No Code Available	17	17
Pain	11	11
Laceration(s)	9	9
Cough	9	9
Discomfort	6	6
No Information	5	5
Swelling	5	5
Hemorrhage/Bleeding	4	4
Hypersensitivity/Allergic reaction	4	4
Vomiting	4	4
Injury	3	3
Numbness	3	3
Inflammation	3	3
Sensitivity of Teeth	3	3
Unspecified Tissue Injury	3	3
No Consequences Or Impact To Patient	3	3
Reaction	3	3
Tooth Fracture	2	2
Burning Sensation	2	2
Anxiety	2	2
Emotional Changes	2	2
Unspecified Gastrointestinal Problem	2	2
Abscess	2	2
Needle Stick/Puncture	2	2
Unspecified Infection	1	1
Asthma	1	1
Depression	1	1
Itching Sensation	1	1
Post Traumatic Wound Infection	1	1
Thrombus	1	1
Rash	1	1
Dyspnea	1	1
Dysuria	1	1
Ulceration	1	1
Tingling	1	1
Injection Site Reaction	1	1
Patient Problem/Medical Problem	1	1
Suffocation	1	1
Stomatitis	1	1
Skin Discoloration	1	1
Hypervolemia	1	1
Tachycardia	1	1
No Patient Involvement	1	1
Complaint, Ill-Defined	1	1
Eye Injury	1	1
Chemical Exposure	1	1
Hemoptysis	1	1
Malaise	1	1
Burn(s)	1	1
Thrombosis	1	1