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
Manufacturing, Packaging or Shipping Problem	22	22
Adverse Event Without Identified Device or Use Problem	22	22
Product Quality Problem	20	20
Material Frayed	15	15
Material Puncture/Hole	15	15
Nonstandard Device	15	15
Leak/Splash	11	11
Off-Label Use	10	10
Material Integrity Problem	9	9
Device Contaminated During Manufacture or Shipping	7	7
Device Damaged Prior to Use	7	7
Device Operates Differently Than Expected	5	5
Fluid/Blood Leak	5	5
Hole In Material	5	5
Shipping Damage or Problem	5	5
Stretched	4	4
Inaccurate Information	4	4
Flaked	4	4
Unraveled Material	3	3
Use of Device Problem	3	3
Material Twisted/Bent	3	3
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Incomplete or Missing Packaging	2	2
Improper or Incorrect Procedure or Method	2	2
Device Contaminated at the User Facility	2	2
Patient Device Interaction Problem	2	2
Material Perforation	2	2
No Apparent Adverse Event	2	2
Physical Property Issue	1	1
Peeled/Delaminated	1	1
Material Disintegration	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Operational Issue	1	1
Material Deformation	1	1
Material Rupture	1	1
Device Issue	1	1
Contamination /Decontamination Problem	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
Hemorrhage/Bleeding	29	29
Blood Loss	28	28
No Consequences Or Impact To Patient	18	18
No Patient Involvement	16	16
No Known Impact Or Consequence To Patient	15	15
No Information	8	8
Insufficient Information	7	7
Fungal Infection	5	5
Pseudoaneurysm	5	5
No Code Available	4	4
Aneurysm	4	4
Bacterial Infection	4	4
Death	3	3
Failure of Implant	2	2
Not Applicable	2	2
Ventricular Fibrillation	2	2
Stenosis	2	2
Paraplegia	2	2
Unspecified Infection	1	1
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Ischemia	1	1
Exsanguination	1	1
Hemolytic Anemia	1	1
Irritation	1	1
Chest Pain	1	1
Pain	1	1
Renal Failure	1	1
Cancer	1	1