TPLC - Total Product Life Cycle

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Device	stylet for catheter, gastro-urology
Regulation Description	Urological catheter and accessories.
Product Code	EZB
Regulation Number	876.5130
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Flaked	169	170
Adverse Event Without Identified Device or Use Problem	135	135
Detachment of Device or Device Component	124	124
Break	78	78
Material Fragmentation	52	53
Peeled/Delaminated	45	45
Material Protrusion/Extrusion	37	37
Improper Chemical Reaction	27	27
Difficult to Advance	24	24
Unraveled Material	22	22
Material Twisted/Bent	22	23
Nonstandard Device	12	12
Difficult to Insert	12	13
Device-Device Incompatibility	9	9
Accessory Incompatible	8	8
Device Contamination with Chemical or Other Material	8	8
Difficult to Remove	8	8
Material Deformation	8	8
Use of Device Problem	8	8
Deformation Due to Compressive Stress	7	8
Entrapment of Device	7	7
Defective Device	6	6
Inadequacy of Device Shape and/or Size	6	6
Patient Device Interaction Problem	6	6
Material Split, Cut or Torn	5	5
Missing Information	5	5
Insufficient Information	5	5
Unsealed Device Packaging	5	5
Material Integrity Problem	5	5
Device Handling Problem	5	5
Tear, Rip or Hole in Device Packaging	4	4
Material Separation	4	4
Sharp Edges	4	4
Material Too Rigid or Stiff	4	4
Incorrect Measurement	3	3
Component Misassembled	3	3
Device Contaminated During Manufacture or Shipping	3	3
Scratched Material	2	2
Failure to Advance	2	2
Component Missing	1	1
Positioning Failure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Shipping Damage or Problem	1	1
Contamination	1	1
Failure to Unfold or Unwrap	1	1
Expiration Date Error	1	1
Wrong Label	1	1
Material Puncture/Hole	1	1
Material Invagination	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	526	530
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	41	41
Foreign Body In Patient	32	32
Perforation	22	22
Insufficient Information	20	20
Hemorrhage/Bleeding	19	19
Fever	18	18
Exposure to Body Fluids	16	16
Hematuria	15	15
Pain	12	12
Sepsis	10	10
Urinary Tract Infection	9	9
Laceration(s)	9	9
Unspecified Infection	7	7
Pancreatitis	7	7
Hematoma	7	7
Unspecified Tissue Injury	7	7
Septic Shock	5	5
Low Blood Pressure/ Hypotension	4	4
Swelling/ Edema	4	4
Renal Failure	4	4
Device Embedded In Tissue or Plaque	3	3
No Patient Involvement	3	3
Discomfort	3	3
Thrombosis/Thrombus	3	3
Multiple Organ Failure	3	3
Obstruction/Occlusion	3	3
Urinary Incontinence	3	3
Nausea	3	3
Abdominal Pain	3	3
Pleural Effusion	2	2
Chills	2	2
Cardiac Arrest	2	2
Extravasation	2	2
Anemia	2	2
No Consequences Or Impact To Patient	2	2
Urinary Retention	1	1
Vomiting	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Prolapse	1	1
Abscess	1	1
Asystole	1	1
Inflammation	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Dysuria	1	1
Deformity/ Disfigurement	1	1
Cancer	1	1
Ischemia Stroke	1	1
Fistula	1	1