TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	834	1211
Physical Resistance/Sticking	251	251
Complete Blockage	210	213
Device Appears to Trigger Rejection	99	99
Migration	95	95
Mechanical Jam	50	50
Malposition of Device	50	172
Fracture	50	50
Appropriate Term/Code Not Available	41	51
Device Dislodged or Dislocated	38	161
Material Twisted/Bent	38	38
Obstruction of Flow	27	27
Break	24	32
Failure to Eject	19	19
Off-Label Use	14	14
Retraction Problem	14	14
Improper or Incorrect Procedure or Method	12	12
Dull, Blunt	11	11
Partial Blockage	10	10
Defective Device	9	9
Failure to Deliver	9	9
Infusion or Flow Problem	7	7
Activation, Positioning or Separation Problem	5	5
Material Deformation	5	5
Positioning Failure	5	5
Failure to Advance	4	4
No Apparent Adverse Event	4	4
Delivered as Unsterile Product	4	4
Use of Device Problem	4	4
Separation Failure	4	4
Positioning Problem	3	3
Patient-Device Incompatibility	3	3
Activation Problem	3	3
No Flow	3	3
Difficult to Insert	2	2
Device Difficult to Setup or Prepare	2	10
Difficult to Remove	2	2
Contamination	2	2
Defective Component	2	2
Insufficient Information	2	2
Device Contamination with Chemical or Other Material	2	2
Unintended Movement	2	2
Filtration Problem	2	2
Migration or Expulsion of Device	2	2
Material Fragmentation	1	1
Ejection Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Discolored	1	1
Unintended Ejection	1	1
Excess Flow or Over-Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	449	701
No Clinical Signs, Symptoms or Conditions	372	381
Eye Injury	280	410
Intraocular Pressure Decreased	209	217
Erosion	136	136
Endophthalmitis	131	133
Loss of Vision	115	239
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	103	107
Visual Impairment	100	104
Hyphema	90	215
Insufficient Information	69	69
Failure of Implant	52	52
No Consequences Or Impact To Patient	52	52
Fibrosis	51	51
Glaucoma	51	51
Hemorrhage/Bleeding	50	50
Intraocular Pressure, Delayed, Uncontrolled	44	44
Corneal Edema	43	43
Corneal Stromal Edema	39	44
Macular Edema	38	38
Uveitis	36	158
Retinal Detachment	34	37
Inflammation	32	155
Vitreous Hemorrhage	31	31
Corneal Decompensation	31	31
Intraocular Infection	30	30
Therapeutic Response, Decreased	27	27
No Code Available	24	24
Cataract	23	145
Blurred Vision	23	23
Keratitis	22	22
Fluid Discharge	21	21
Wound Dehiscence	20	20
Pain	18	18
Iritis	18	140
Eye Infections	16	16
No Known Impact Or Consequence To Patient	16	16
Foreign Body In Patient	15	137
Adhesion(s)	14	136
Eye Pain	13	13
Hyperemia	12	12
Corneal Abrasion	11	11
Corneal Touch	10	10
Corneal Clouding/Hazing	10	10
Corneal Ulcer	9	9
Perforation	8	8
No Patient Involvement	7	7
Collapse	7	7
Discomfort	6	6
Unspecified Eye / Vision Problem	6	10