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
Product Quality Problem	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Nonstandard Device	15	15
Off-Label Use	8	8
Material Puncture/Hole	8	8
Device Damaged Prior to Use	7	7
Shipping Damage or Problem	5	5
Material Frayed	4	4
Device Contaminated During Manufacture or Shipping	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Integrity Problem	4	4
Inaccurate Information	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
Flaked	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 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	27	27
No Patient Involvement	9	9
Insufficient Information	7	7
No Consequences Or Impact To Patient	7	7
Fungal Infection	4	4
Pseudoaneurysm	4	4
Bacterial Infection	4	4
Ventricular Fibrillation	2	2
Stenosis	2	2
Paraplegia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
Exsanguination	1	1