TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	417	417
Material Separation	159	159
Adverse Event Without Identified Device or Use Problem	53	53
Material Frayed	43	43
Detachment of Device or Device Component	34	34
Material Integrity Problem	18	18
Patient-Device Incompatibility	15	15
Defective Component	15	15
Component Misassembled	13	13
Appropriate Term/Code Not Available	12	12
Material Twisted/Bent	11	11
Use of Device Problem	10	10
Packaging Problem	8	8
Unraveled Material	8	8
Fluid/Blood Leak	6	6
Device Markings/Labelling Problem	6	6
Device Contaminated During Manufacture or Shipping	5	5
Material Split, Cut or Torn	5	5
Product Quality Problem	5	5
Device Slipped	4	4
Difficult to Open or Close	4	4
Contamination /Decontamination Problem	3	3
Difficult to Remove	3	3
Component Missing	3	3
Unsealed Device Packaging	2	2
Component Incompatible	2	2
Migration	2	2
Insufficient Information	1	1
Device Fell	1	1
Missing Information	1	1
Activation, Positioning or Separation Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Mechanics Altered	1	1
Positioning Failure	1	1
Entrapment of Device	1	1
Material Fragmentation	1	1
Loose or Intermittent Connection	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	348	348
No Consequences Or Impact To Patient	245	245
Insufficient Information	27	27
Wound Dehiscence	23	23
Not Applicable	20	20
No Code Available	19	19
Hemorrhage/Bleeding	18	18
Unspecified Infection	17	17
Foreign Body In Patient	16	16
No Known Impact Or Consequence To Patient	13	13
Pain	11	11
No Patient Involvement	10	10
Swelling/ Edema	10	10
No Information	8	8
Unspecified Tissue Injury	8	8
Post Operative Wound Infection	8	8
Blood Loss	6	6
Hypersensitivity/Allergic reaction	6	6
Erythema	6	6
Foreign Body Reaction	5	5
Cyst(s)	5	5
Skin Irritation	5	5
Skin Inflammation	5	5
Unintended Radiation Exposure	4	4
Granuloma	4	4
Inflammation	4	4
Erosion	3	3
Abscess	3	3
Tissue Damage	3	3
Scar Tissue	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Incontinence	3	3
Device Embedded In Tissue or Plaque	3	3
Radiation Exposure, Unintended	2	2
Prolapse	2	2
Impaired Healing	2	2
Numbness	2	2
Obstruction/Occlusion	2	2
Blister	2	2
Abnormal Vaginal Discharge	2	2
Sepsis	2	2
Hematoma	2	2
Fistula	2	2
Itching Sensation	1	1
Laceration(s)	1	1
Necrosis	1	1
Adhesion(s)	1	1
Anaphylactic Shock	1	1
Calcium Deposits/Calcification	1	1
Edema	1	1
Seroma	1	1
Swelling	1	1
Tachycardia	1	1
Weakness	1	1
Urinary Tract Infection	1	1
Scarring	1	1
Low Blood Pressure/ Hypotension	1	1
Paralysis	1	1
Local Reaction	1	1
Respiratory Distress	1	1
Skin Inflammation/ Irritation	1	1
Stenosis	1	1
Urticaria	1	1
Discomfort	1	1
Hematuria	1	1
Tissue Breakdown	1	1
Fluid Discharge	1	1