TPLC - Total Product Life Cycle

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Device	catheter, coude
Regulation Description	Urological catheter and accessories.
Product Code	EZC
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	793	814
Difficult to Remove	528	530
Fluid/Blood Leak	527	576
Burst Container or Vessel	524	537
Material Rupture	495	497
Decrease in Pressure	367	387
Material Fragmentation	260	262
Deflation Problem	255	257
Failure to Infuse	247	266
Inaccurate Flow Rate	244	246
Partial Blockage	210	212
Erratic or Intermittent Display	202	217
Adverse Event Without Identified Device or Use Problem	153	154
Inflation Problem	151	151
Material Split, Cut or Torn	117	120
Device Sensing Problem	114	134
Disconnection	113	113
Patient Device Interaction Problem	105	106
Component Misassembled	103	103
Device Contamination with Chemical or Other Material	63	63
Inadequate or Insufficient Training	54	54
Illegible Information	54	58
Complete Blockage	49	49
Material Invagination	45	45
Component Missing	45	46
Calcified	44	44
Biocompatibility	41	43
Dent in Material	40	40
Incorrect Measurement	40	40
No Display/Image	36	39
Device Handling Problem	36	36
Fracture	34	36
Tear, Rip or Hole in Device Packaging	34	35
Device Dislodged or Dislocated	31	31
Material Twisted/Bent	31	31
Deformation Due to Compressive Stress	29	29
Nonstandard Device	28	31
Inability to Irrigate	27	27
Inadequate Instructions for Healthcare Professional	27	27
Difficult to Insert	25	26
Missing Information	25	26
Unclear Information	22	22
Short Fill	21	21
Material Protrusion/Extrusion	20	20
Naturally Worn	17	17
Use of Device Problem	17	17
Gel Leak	17	17
Insufficient Information	16	16
Wrong Label	15	15
Physical Resistance/Sticking	11	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5112	5235
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	472	478
Pain	178	178
Foreign Body In Patient	136	136
Urinary Tract Infection	121	122
No Consequences Or Impact To Patient	105	105
Hematuria	89	89
Discomfort	67	67
Insufficient Information	33	34
No Patient Involvement	26	26
Exposure to Body Fluids	25	25
Unspecified Infection	24	24
Tissue Breakdown	24	25
No Code Available	24	24
Skin Inflammation/ Irritation	21	22
Urinary Retention	21	21
Fistula	20	20
Hemorrhage/Bleeding	17	17
Incontinence	17	17
Hypersensitivity/Allergic reaction	16	17
Erosion	16	17
Perforation	16	16
Cancer	14	14
Abdominal Distention	11	11
Inflammation	10	10
Unspecified Gastrointestinal Problem	8	8
Irritability	7	7
Pressure Sores	7	7
Swelling/ Edema	6	6
Abdominal Pain	6	6
Cramp(s) /Muscle Spasm(s)	6	6
Skin Discoloration	5	5
Bacterial Infection	5	5
Abrasion	5	5
Unspecified Tissue Injury	5	5
Distress	4	4
Localized Skin Lesion	4	4
No Known Impact Or Consequence To Patient	4	4
Burning Sensation	4	4
Micturition Urgency	4	4
Itching Sensation	4	4
Sepsis	3	3
Fever	3	3
Irritation	3	3
Rash	3	3
Dysuria	3	3
Urinary Frequency	3	3
Skin Tears	3	3
Laceration(s)	3	3
Convulsion/Seizure	2	2