TPLC - Total Product Life Cycle

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Device	graft, vascular, synthetic/biologic composite
Regulation Description	Vascular graft prosthesis.
Product Code	MAL
Regulation Number	870.3450
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Product Quality Problem	22	22
Off-Label Use	20	20
Adverse Event Without Identified Device or Use Problem	20	20
Material Frayed	16	16
Nonstandard Device	16	16
Material Puncture/Hole	12	12
Manufacturing, Packaging or Shipping Problem	12	12
Device Damaged Prior to Use	7	7
Device Contaminated During Manufacture or Shipping	6	6
Material Integrity Problem	5	5
Patient Device Interaction Problem	5	5
Shipping Damage or Problem	5	5
Insufficient Information	4	4
Stretched	4	4
Inaccurate Information	4	4
Flaked	4	4
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Contamination /Decontamination Problem	2	3
Improper or Incorrect Procedure or Method	2	2
Device Contaminated at the User Facility	2	2
Leak/Splash	1	1
Material Disintegration	1	1
Unsealed Device Packaging	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Material Perforation	1	1
Material Rupture	1	1
Device Handling Problem	1	1
Difficult or Delayed Separation	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	55
Hemorrhage/Bleeding	34	34
No Patient Involvement	13	13
No Consequences Or Impact To Patient	11	11
Blood Loss	9	9
Insufficient Information	9	10
No Known Impact Or Consequence To Patient	6	6
Bacterial Infection	6	6
Fungal Infection	4	4
Pseudoaneurysm	4	4
Hypersensitivity/Allergic reaction	3	3
No Information	2	2
Adhesion(s)	2	2
Ventricular Fibrillation	2	2
Thrombosis/Thrombus	2	2
Stenosis	2	2
Paraplegia	2	2
Death	1	1
Failure of Implant	1	1
Exsanguination	1	1
Hemolytic Anemia	1	1
Renal Failure	1	1
Cancer	1	1