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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device activated whole blood clotting time
Product CodeJBP
Regulation Number 864.7140
Device Class 2


Premarket Reviews
ManufacturerDecision
SIENCO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 10 10
2021 9 9
2022 7 7
2023 17 17
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Chest Pain 11 11
No Information 6 6
No Code Available 4 4
Myocardial Infarction 4 4
Atrial Fibrillation 3 3
Pain 3 3
Peripheral Vascular Disease 2 2
Ventricular Tachycardia 2 2
Dizziness 1 1
Diabetic Ketoacidosis 1 1
Numbness 1 1
Respiratory Distress 1 1
ST Segment Elevation 1 1
Transient Ischemic Attack 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Heart Failure/Congestive Heart Failure 1 1
Swelling/ Edema 1 1
Exposure to Body Fluids 1 1
Cardiomyopathy 1 1
Cellulitis 1 1
Nausea 1 1
Angina 1 1
Aortic Valve Stenosis 1 1
Coagulation Disorder 1 1
Dyspnea 1 1
Cardiac Enzyme Elevation 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
High Blood Pressure/ Hypertension 1 1
Laceration(s) 1 1

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