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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lipoprotein, low density, removal
Product CodeMMY
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 2 0 3 1 0 5 7 3 3 4 2 3 3 1 0

MDR Year MDR Reports MDR Events
2014 6 6
2015 1 1
2016 5 5
2017 2 2
2018 4 4
2019 2 2
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Patient Device Interaction Problem 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Blood Pressure/ Hypotension 16 16
Loss of consciousness 7 7
Apheresis 6 6
Edema 4 4
Death 3 3
Shock 2 2
Anaphylactic Shock 2 2
Cardiopulmonary Arrest 2 2
Anaphylactoid 2 2
Hypovolemia 2 2
Malaise 1 1
Sweating 1 1
Sudden Cardiac Death 1 1
No Known Impact Or Consequence To Patient 1 1
Arrhythmia 1 1
Cardiac Arrest 1 1
Embolism 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Intraventricular 1 1
Hypersensitivity/Allergic reaction 1 1
Tachycardia 1 1
Torsades-de-Pointes 1 1
Heart Failure 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Dyspnea 1 1
Hypovolemic Shock 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kaneka America Corp II Apr-09-2022
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