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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device timer, clot, automated
Regulation Description Coagulation instrument.
Product CodeGKN
Regulation Number 864.5400
Device Class 2

MDR Year MDR Reports MDR Events
2015 3 3
2017 2 2
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Incorrect Measurement 1 1
Device Operates Differently Than Expected 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aortic Valve Stenosis 3 3
Congestive Heart Failure 2 2
Stroke/CVA 2 2
Death 1 1
Hemorrhage/Bleeding 1 1
Myocardial Infarction 1 1
Non specific EKG/ECG Changes 1 1
Hemorrhage, Cerebral 1 1
Thrombus 1 1
Transient Ischemic Attack 1 1
Calcium Deposits/Calcification 1 1
Corneal Pannus 1 1
Aortic Insufficiency 1 1

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