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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device glue, surgical, arteries
Product CodeMUQ
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
3 3 5 0 2 0

MDR Year MDR Reports MDR Events
2017 31 31
2018 25 25
2019 39 39
2020 25 25
2021 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 105 105
Insufficient Information 33 33
Appropriate Term/Code Not Available 10 10
Off-Label Use 6 6
Use of Device Problem 3 3
Migration 3 3
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Chemical Problem 1 1
Unintended Movement 1 1
Loss of or Failure to Bond 1 1
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pseudoaneurysm 32 32
Death 20 20
Inflammation 12 12
Embolism 11 11
Unspecified Infection 9 9
No Code Available 9 9
Fistula 6 6
Aneurysm 6 6
Reaction 6 6
Aortic Dissection 6 6
Blood Loss 6 6
Seroma 5 5
Stroke/CVA 5 5
Fever 4 4
Neurological Deficit/Dysfunction 4 4
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Insufficient Information 3 3
Necrosis 3 3
Brain Injury 3 3
Anaphylactic Shock 3 3
Granuloma 3 3
Cerebrospinal Fluid Leakage 3 3
Aortic Regurgitation 2 2
Abscess 2 2
Bacterial Infection 2 2
Myocardial Infarction 2 2
Ischemia 2 2
Hemorrhage/Bleeding 2 2
Hepatitis 2 2
Rupture 2 2
Meningitis 2 2
Pain 2 2
Thromboembolism 2 2
Reaction to Medicinal Component of Device 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Valvular Stenosis 1 1
Vascular Dissection 1 1
Cancer 1 1
Pericardial Effusion 1 1
Speech Disorder 1 1
Foreign Body Embolism 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Solid Tumour 1 1
Swelling/ Edema 1 1
Fluid Discharge 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Pulmonary Valve Stenosis 1 1
Undesired Nerve Stimulation 1 1
Occlusion 1 1
Spinal Column Injury 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Loss of Vision 1 1
Weakness 1 1
Tingling 1 1
HIV, Human Immunodeficiency Virus 1 1
No Consequences Or Impact To Patient 1 1
Coma 1 1
Spinal Cord Injury 1 1
Post Operative Wound Infection 1 1
Discharge 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Cardiogenic Shock 1 1
Stenosis 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Impaired Healing 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Foreign Body Reaction 1 1
Itching Sensation 1 1
Mitral Regurgitation 1 1
Hematoma 1 1
Calcium Deposits/Calcification 1 1
Intimal Dissection 1 1
Arrhythmia 1 1
Atherosclerosis 1 1
Cyst(s) 1 1
Infarction, Cerebral 1 1
Embolus 1 1
Erythema 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Dec-15-2021
2 CryoLife, Inc. II Jul-26-2018
3 CryoLife, Inc. II Jun-23-2017
4 Siemens Medical Solutions USA, Inc II Nov-16-2021
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