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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2019 28 28
2020 24 24
2021 34 34
2022 21 21
2023 17 17
2024 10 10

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

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Sep-24-2019
2 Maquet Cardiovascular, LLC II Mar-07-2022
3 Maquet Cardiovascular, LLC II Dec-20-2021
4 Maquet Cardiovascular, LLC II May-04-2020
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