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	818	839
Difficult to Remove	537	539
Fluid/Blood Leak	534	583
Material Rupture	526	527
Burst Container or Vessel	519	532
Decrease in Pressure	367	387
Material Fragmentation	262	264
Deflation Problem	254	256
Inaccurate Flow Rate	253	255
Failure to Infuse	248	267
Erratic or Intermittent Display	210	225
Partial Blockage	208	210
Inflation Problem	157	157
Adverse Event Without Identified Device or Use Problem	153	154
Material Split, Cut or Torn	121	124
Disconnection	118	118
Device Sensing Problem	113	133
Patient Device Interaction Problem	107	108
Component Misassembled	105	105
Device Contamination with Chemical or Other Material	64	64
Illegible Information	54	58
Inadequate or Insufficient Training	54	54
Complete Blockage	51	51
Material Invagination	49	49
Calcified	45	45
Component Missing	44	45
Biocompatibility	41	43
Dent in Material	41	41
Incorrect Measurement	40	40
Device Handling Problem	36	36
No Display/Image	36	39
Fracture	35	37
Tear, Rip or Hole in Device Packaging	33	34
Material Twisted/Bent	31	31
Device Dislodged or Dislocated	30	30
Deformation Due to Compressive Stress	29	29
Nonstandard Device	28	31
Inadequate Instructions for Healthcare Professional	27	27
Inability to Irrigate	26	26
Missing Information	26	27
Difficult to Insert	25	26
Unclear Information	23	23
Short Fill	22	22
Material Protrusion/Extrusion	21	21
Use of Device Problem	19	19
Gel Leak	17	17
Naturally Worn	17	17
Wrong Label	16	16
Insufficient Device Problem Information	16	16
Expiration Date Error	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5242	5365
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	482	488
Pain	183	183
Foreign Body In Patient	144	144
Urinary Tract Infection	122	123
No Consequences Or Impact To Patient	105	105
Hematuria	90	90
Discomfort	71	71
Insufficient Information	33	34
Exposure to Body Fluids	27	27
No Patient Involvement	26	26
Unspecified Infection	24	24
No Code Available	24	24
Tissue Breakdown	24	25
Skin Inflammation/ Irritation	22	23
Urinary Retention	21	21
Fistula	20	20
Perforation	18	18
Incontinence	17	17
Hemorrhage/Blood Loss/Bleeding	17	17
Hypersensitivity/Allergic reaction	16	17
Erosion	16	17
Cancer	14	14
Abdominal Distention	13	13
Inflammation	11	11
Unspecified Gastrointestinal Problem	8	8
Irritability	7	7
Pressure Sore/Ulcer	7	7
Cramp(s) /Muscle Spasm(s)	6	6
Swelling/ Edema	6	6
Abdominal Pain	6	6
Unspecified Tissue Injury	6	6
Bacterial Infection	5	5
Skin Discoloration	5	5
Abrasion	5	5
Itching Sensation	4	4
Burning Sensation	4	4
Micturition Urgency	4	4
Localized Skin Lesion	4	4
Distress	4	4
No Known Impact Or Consequence To Patient	4	4
Irritation	3	3
Laceration(s)	3	3
Fever	3	3
Sepsis	3	3
Dysuria	3	3
Rash	3	3
Skin Tears	3	3
Urinary Frequency / Polyuria	3	3
Convulsion/Seizure	2	2