TPLC - Total Product Life Cycle

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Device	holder, ureteral catheter
Regulation Description	Urological catheter and accessories.
Product Code	EYJ
Regulation Number	876.5130
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disconnection	158	159
Loss of or Failure to Bond	83	84
Material Fragmentation	61	61
Fitting Problem	42	42
Difficult to Open or Close	27	28
Nonstandard Device	21	22
Patient Device Interaction Problem	10	10
Sharp Edges	8	8
Device Handling Problem	8	8
Component Misassembled	6	6
Component Missing	5	5
Incorrect Measurement	5	5
Biocompatibility	5	5
Material Split, Cut or Torn	4	4
Material Integrity Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Break	3	5
Use of Device Problem	2	2
Material Twisted/Bent	2	2
Material Protrusion/Extrusion	2	2
Deformation Due to Compressive Stress	2	2
Mechanical Problem	1	1
Malposition of Device	1	1
Restricted Flow rate	1	1
Material Puncture/Hole	1	2
Unintended Movement	1	11
Insufficient Information	1	1
Expiration Date Error	1	1
Shipping Damage or Problem	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1
No Apparent Adverse Event	1	1
Illegible Information	1	1
Inadequate or Insufficient Training	1	1
Improper Chemical Reaction	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	414	420
No Consequences Or Impact To Patient	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	20
Discomfort	8	9
Skin Inflammation/ Irritation	5	5
Urinary Retention	5	5
Pain	5	6
Pressure Sores	4	4
Urinary Tract Infection	4	4
Skin Tears	3	3
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Local Reaction	2	2
Blister	2	2
Skin Discoloration	2	2
No Patient Involvement	2	2
Erosion	2	2
Irritability	2	2
Cramp(s) /Muscle Spasm(s)	1	1
Rash	1	1
Insufficient Information	1	1
Laceration(s)	1	1
Unspecified Tissue Injury	1	1
Tissue Breakdown	1	1