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	332	332
Break	214	214
Product Quality Problem	82	82
Material Separation	40	40
Material Fragmentation	24	24
Adverse Event Without Identified Device or Use Problem	14	14
Device Slipped	13	13
Insufficient Information	8	8
Defective Device	7	10
Entrapment of Device	4	4
Material Integrity Problem	4	4
Manufacturing, Packaging or Shipping Problem	2	2
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1
Device Contamination with Chemical or Other Material	1	2
Device Contaminated During Manufacture or Shipping	1	1
Fluid/Blood Leak	1	1
Material Disintegration	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Material Too Rigid or Stiff	1	1
Physical Resistance/Sticking	1	1
Unintended Electrical Shock	1	1
Appropriate Term/Code Not Available	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	316	316
Insufficient Information	200	204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	53	53
Foreign Body In Patient	52	52
Device Embedded In Tissue or Plaque	47	47
Choking	34	34
Laceration(s)	10	10
Pain	10	10
Cough	9	9
Tooth Fracture	6	6
Unspecified Tissue Injury	4	4
Discomfort	3	3
Hemorrhage/Bleeding	3	3
Unspecified Gastrointestinal Problem	2	2
Inflammation	2	2
Chemical Exposure	2	2
Vomiting	2	2
Numbness	2	2
Anxiety	2	2
Unspecified Infection	1	1
Injection Site Reaction	1	1
Hypersensitivity/Allergic reaction	1	1
Emotional Changes	1	1
Dysuria	1	1
Hemoptysis	1	1
Malaise	1	1
Asthma	1	1
Foreign Body Reaction	1	1
Post Traumatic Wound Infection	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Depression	1	1
Dyspnea	1	1
Ulcer	1	1
Sore Throat	1	1
Stomatitis	1	1
Hypervolemia	1	1