TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	464	464
Material Separation	166	166
Adverse Event Without Identified Device or Use Problem	55	55
Detachment of Device or Device Component	45	45
Material Frayed	43	43
Patient-Device Incompatibility	30	30
Appropriate Term/Code Not Available	21	21
Material Integrity Problem	20	20
Defective Component	15	15
Component Misassembled	13	13
Material Twisted/Bent	12	12
Use of Device Problem	10	10
Unraveled Material	9	9
Packaging Problem	8	8
Device Markings/Labelling Problem	7	7
Difficult to Open or Close	6	6
Fluid/Blood Leak	6	6
Material Split, Cut or Torn	5	5
Device Contaminated During Manufacture or Shipping	5	5
Product Quality Problem	5	5
Migration	5	5
Device Slipped	4	4
Difficult to Remove	3	3
Contamination /Decontamination Problem	3	3
Component Missing	3	3
Delivered as Unsterile Product	3	3
Unsealed Device Packaging	2	2
Component Incompatible	2	2
Activation, Positioning or Separation Problem	1	1
Entrapment of Device	1	1
Device Fell	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Fragmentation	1	1
Positioning Failure	1	1
Mechanics Altered	1	1
Material Deformation	1	1
Missing Information	1	1
Human-Device Interface Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	412	412
No Consequences Or Impact To Patient	245	245
Insufficient Information	45	45
Wound Dehiscence	28	28
Not Applicable	20	20
No Code Available	19	19
Hemorrhage/Bleeding	19	19
Unspecified Infection	18	18
Foreign Body In Patient	18	18
Pain	13	13
No Known Impact Or Consequence To Patient	13	13
Swelling/ Edema	11	11
No Patient Involvement	10	10
Post Operative Wound Infection	9	9
No Information	8	8
Unspecified Tissue Injury	8	8
Hypersensitivity/Allergic reaction	7	7
Blood Loss	6	6
Erythema	6	6
Skin Irritation	5	5
Inflammation	5	5
Cyst(s)	5	5
Foreign Body Reaction	5	5
Skin Inflammation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unintended Radiation Exposure	4	4
Granuloma	4	4
Erosion	4	4
Incontinence	4	4
Device Embedded In Tissue or Plaque	3	3
Tissue Damage	3	3
Abscess	3	3
Prolapse	3	3
Scar Tissue	3	3
Urinary Tract Infection	2	2
Fistula	2	2
Fluid Discharge	2	2
Numbness	2	2
Blister	2	2
Obstruction/Occlusion	2	2
Hematoma	2	2
Skin Inflammation/ Irritation	2	2
Abnormal Vaginal Discharge	2	2
Sepsis	2	2
Radiation Exposure, Unintended	2	2
Impaired Healing	2	2
Discomfort	1	1
Fever	1	1
Seroma	1	1
Paralysis	1	1