TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	960	960
Adverse Event Without Identified Device or Use Problem	487	487
Difficult to Remove	478	478
Improper Chemical Reaction	426	426
Material Twisted/Bent	408	408
Difficult to Insert	356	356
Deflation Problem	353	353
Component Misassembled	300	300
Material Rupture	263	263
Decrease in Pressure	255	255
Incorrect Measurement	251	251
Material Puncture/Hole	228	228
Fluid/Blood Leak	220	220
Short Fill	219	219
Nonstandard Device	217	217
Component Missing	215	215
Product Quality Problem	182	182
Sharp Edges	176	176
Partial Blockage	158	158
Device Misassembled During Manufacturing /Shipping	145	145
Biocompatibility	122	122
Misassembled	119	119
Failure to Infuse	111	111
Break	111	111
Contamination /Decontamination Problem	110	110
Inaccurate Flow Rate	101	101
Device Damaged Prior to Use	99	99
Leak/Splash	97	97
Material Fragmentation	97	97
Material Split, Cut or Torn	81	81
Inadequacy of Device Shape and/or Size	81	81
Patient-Device Incompatibility	77	77
Patient Device Interaction Problem	69	69
Material Too Rigid or Stiff	68	68
Tear, Rip or Hole in Device Packaging	67	67
Unsealed Device Packaging	65	65
Device Handling Problem	65	65
Material Integrity Problem	61	61
Difficult to Open or Remove Packaging Material	54	54
Scratched Material	54	54
Defective Device	53	53
Inflation Problem	52	52
Material Protrusion/Extrusion	51	51
Material Deformation	51	51
Device Slipped	51	51
Inability to Irrigate	49	49
Device Contamination with Chemical or Other Material	49	49
Device Fell	46	46
Unintended Deflation	40	40
No Flow	39	39

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3804	3804
No Consequences Or Impact To Patient	1449	1449
No Known Impact Or Consequence To Patient	1041	1041
Urinary Tract Infection	537	537
Pain	500	500
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	424	424
No Patient Involvement	315	315
Patient Problem/Medical Problem	235	235
Discomfort	202	202
Hemorrhage/Bleeding	180	180
Hematuria	98	98
Blood Loss	83	83
Foreign Body In Patient	72	72
Unspecified Infection	65	65
Insufficient Information	65	65
No Code Available	55	55
Bacterial Infection	53	53
Urinary Retention	42	42
Sepsis	25	25
Abdominal Distention	25	25
Skin Inflammation/ Irritation	23	23
Irritation	22	22
Tissue Breakdown	22	22
Abrasion	21	21
Abdominal Pain	17	17
No Information	15	16
Perforation	14	14
Swelling/ Edema	13	13
Laceration(s)	13	13
Bruise/Contusion	13	13
Irritability	12	12
Injury	12	12
Tissue Damage	11	11
Incontinence	11	11
Fistula	10	10
Fever	9	9
Swelling	9	9
Obstruction/Occlusion	9	9
Exposure to Body Fluids	8	8
Skin Discoloration	8	8
Inflammation	8	8
Cancer	7	7
Septic Shock	7	7
Hematoma	7	7
Urinary Incontinence	7	7
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	7	7
Anemia	6	6
Low Blood Pressure/ Hypotension	6	6
Cramp(s) /Muscle Spasm(s)	6	6