TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	20	20
Product Quality Problem	20	20
Nonstandard Device	15	15
Material Puncture/Hole	12	12
Manufacturing, Packaging or Shipping Problem	11	11
Off-Label Use	10	10
Material Frayed	9	9
Device Damaged Prior to Use	7	7
Device Contaminated During Manufacture or Shipping	6	6
Material Integrity Problem	5	5
Shipping Damage or Problem	5	5
Stretched	4	4
Inaccurate Information	4	4
Flaked	4	4
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Patient Device Interaction Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Device Contaminated at the User Facility	2	2
Leak/Splash	1	1
Material Disintegration	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Material Perforation	1	1
Material Rupture	1	1
Difficult or Delayed Separation	1	1
Appropriate Term/Code Not Available	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
Hemorrhage/Bleeding	28	28
No Patient Involvement	13	13
No Consequences Or Impact To Patient	11	11
Blood Loss	9	9
Insufficient Information	7	7
No Known Impact Or Consequence To Patient	6	6
Fungal Infection	4	4
Pseudoaneurysm	4	4
Bacterial Infection	4	4
No Information	2	2
Ventricular Fibrillation	2	2
Stenosis	2	2
Paraplegia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Failure of Implant	1	1
Exsanguination	1	1
Hemolytic Anemia	1	1
Renal Failure	1	1
Cancer	1	1