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	20	20
Adverse Event Without Identified Device or Use Problem	17	17
Nonstandard Device	15	15
Material Puncture/Hole	12	12
Material Frayed	9	9
Manufacturing, Packaging or Shipping Problem	9	9
Device Damaged Prior to Use	7	7
Off-Label Use	6	6
Device Contaminated During Manufacture or Shipping	6	6
Material Integrity Problem	5	5
Shipping Damage or Problem	5	5
Stretched	4	4
Flaked	4	4
Inaccurate Information	4	4
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Device Contaminated at the User Facility	2	2
Patient Device Interaction Problem	2	2
No Apparent Adverse Event	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Perforation	1	1
Material Twisted/Bent	1	1
Contamination /Decontamination Problem	1	1
Material Rupture	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	40	40
Hemorrhage/Bleeding	21	21
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
Pseudoaneurysm	4	4
Fungal Infection	4	4
Bacterial Infection	4	4
Paraplegia	2	2
Stenosis	2	2
No Information	2	2
Ventricular Fibrillation	2	2
Cancer	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemolytic Anemia	1	1
Death	1	1
Exsanguination	1	1
Failure of Implant	1	1
Renal Failure	1	1