TPLC - Total Product Life Cycle

show TPLC since

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	723	744
Burst Container or Vessel	524	537
Fluid/Blood Leak	510	559
Difficult to Remove	490	492
Material Rupture	434	436
Decrease in Pressure	365	385
Deflation Problem	246	248
Failure to Infuse	245	264
Material Fragmentation	243	245
Inaccurate Flow Rate	225	227
Partial Blockage	210	212
Erratic or Intermittent Display	197	212
Adverse Event Without Identified Device or Use Problem	150	151
Inflation Problem	136	136
Device Sensing Problem	113	133
Disconnection	109	109
Material Split, Cut or Torn	107	110
Patient Device Interaction Problem	103	104
Component Misassembled	95	95
Device Contamination with Chemical or Other Material	56	56
Illegible Information	54	58
Inadequate or Insufficient Training	54	54
Component Missing	44	45
Material Invagination	43	43
Calcified	42	42
Biocompatibility	41	43
Incorrect Measurement	40	40
Complete Blockage	39	39
Dent in Material	37	37
Device Handling Problem	36	36
No Display/Image	35	38
Fracture	34	36
Tear, Rip or Hole in Device Packaging	33	34
Device Dislodged or Dislocated	29	29
Material Twisted/Bent	29	29
Inadequate Instructions for Healthcare Professional	27	27
Deformation Due to Compressive Stress	27	27
Difficult to Insert	25	26
Missing Information	24	25
Nonstandard Device	23	26
Inability to Irrigate	23	23
Short Fill	21	21
Material Protrusion/Extrusion	21	21
Gel Leak	17	17
Unclear Information	17	17
Insufficient Information	17	17
Naturally Worn	16	16
Wrong Label	14	14
Use of Device Problem	13	13
Expiration Date Error	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4858	4981
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	438	444
Pain	172	172
Foreign Body In Patient	128	128
Urinary Tract Infection	116	117
No Consequences Or Impact To Patient	105	105
Hematuria	87	87
Discomfort	62	62
Insufficient Information	33	34
No Patient Involvement	26	26
Unspecified Infection	24	24
Tissue Breakdown	24	25
No Code Available	24	24
Exposure to Body Fluids	22	22
Urinary Retention	21	21
Fistula	20	20
Skin Inflammation/ Irritation	17	18
Incontinence	17	17
Hypersensitivity/Allergic reaction	16	17
Perforation	16	16
Hemorrhage/Bleeding	15	15
Erosion	15	16
Cancer	14	14
Abdominal Distention	11	11
Inflammation	10	10
Unspecified Gastrointestinal Problem	8	8
Irritability	7	7
Pressure Sores	7	7
Abdominal Pain	6	6
Swelling/ Edema	6	6
Abrasion	5	5
Unspecified Tissue Injury	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Skin Discoloration	5	5
Bacterial Infection	4	4
Micturition Urgency	4	4
No Known Impact Or Consequence To Patient	4	4
Localized Skin Lesion	4	4
Rash	3	3
Burning Sensation	3	3
Irritation	3	3
Fever	3	3
Laceration(s)	3	3
Skin Tears	3	3
Sepsis	3	3
Distress	3	3
Chills	2	2
Obstruction/Occlusion	2	2
Calcium Deposits/Calcification	2	2
Local Reaction	2	2