TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	786	786
Break	569	569
Fluid/Blood Leak	239	239
Material Separation	228	228
Defective Component	206	206
Adverse Event Without Identified Device or Use Problem	142	142
Leak/Splash	114	114
Material Fragmentation	89	89
Crack	86	86
Infusion or Flow Problem	80	80
Device Contaminated During Manufacture or Shipping	71	71
Device Contamination with Chemical or Other Material	66	66
Dull, Blunt	58	58
Suction Problem	46	46
Disconnection	44	44
Unraveled Material	42	42
Appropriate Term/Code Not Available	41	41
Detachment of Device or Device Component	40	40
Material Integrity Problem	37	37
Difficult to Remove	35	35
Entrapment of Device	29	29
Obstruction of Flow	28	28
No Apparent Adverse Event	25	25
Detachment Of Device Component	22	22
Contamination /Decontamination Problem	22	22
Deformation Due to Compressive Stress	18	18
Material Split, Cut or Torn	17	17
Device Damaged Prior to Use	16	16
Suction Failure	16	16
Material Puncture/Hole	15	15
Material Deformation	15	15
Material Twisted/Bent	14	14
Restricted Flow rate	13	13
Component Misassembled	13	13
Use of Device Problem	12	12
Device Operates Differently Than Expected	12	12
Failure to Advance	12	12
Kinked	12	12
Physical Resistance/Sticking	11	11
Fitting Problem	11	11
Misassembled	11	11
Tear, Rip or Hole in Device Packaging	11	11
Improper or Incorrect Procedure or Method	10	10
Device Markings/Labelling Problem	10	10
Insufficient Information	10	10
Component Missing	9	9
Particulates	9	9
Material Frayed	9	9
Partial Blockage	8	8
Migration or Expulsion of Device	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1770	1770
No Consequences Or Impact To Patient	341	341
No Known Impact Or Consequence To Patient	293	293
Foreign Body In Patient	239	239
No Patient Involvement	92	92
Insufficient Information	71	71
No Code Available	67	67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	57	57
Unspecified Infection	51	51
Not Applicable	48	48
Device Embedded In Tissue or Plaque	42	42
No Information	29	29
Hematoma	27	27
Pain	24	24
Pneumothorax	23	23
Hemorrhage/Bleeding	21	21
Seroma	20	20
Fistula	19	19
Failure to Anastomose	18	18
Post Operative Wound Infection	14	14
Injury	12	12
Wound Dehiscence	11	11
Patient Problem/Medical Problem	11	11
Bacterial Infection	10	10
Endophthalmitis	9	9
Abscess	9	9
Death	8	8
Failure of Implant	8	8
Pleural Effusion	8	8
Inflammation	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Obstruction/Occlusion	8	8
Blood Loss	8	8
Pneumonia	7	7
Necrosis	7	7
Capsular Bag Tear	7	7
Fever	6	6
Sepsis	5	5
Cardiac Tamponade	5	5
Low Blood Pressure/ Hypotension	4	4
Hypoxia	4	4
Unspecified Tissue Injury	4	4
Uveitis	4	4
Erythema	4	4
Chest Pain	4	4
Abdominal Pain	4	4
Impaired Healing	4	4
Atrial Fibrillation	4	4
Cellulitis	3	3
Urinary Tract Infection	3	3