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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device glue, surgical, arteries
Product CodeMUQ
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
5 3 3 5 0 1

MDR Year MDR Reports MDR Events
2016 28 28
2017 31 31
2018 25 25
2019 39 39
2020 25 25
2021 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 122 122
Insufficient Information 35 35
Appropriate Term/Code Not Available 15 15
Off-Label Use 6 6
Use of Device Problem 3 3
Migration 3 3
Failure To Adhere Or Bond 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Chemical Problem 1 1
Device Operates Differently Than Expected 1 1
Improper Chemical Reaction 1 1
Loss of or Failure to Bond 1 1
Contamination 1 1
Material Fragmentation 1 1
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Material Too Soft/Flexible 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pseudoaneurysm 34 34
Death 20 20
Inflammation 19 19
Unspecified Infection 18 18
Embolism 14 14
No Code Available 11 11
Fever 8 8
Reaction 7 7
Fistula 6 6
Aneurysm 6 6
Aortic Dissection 6 6
Blood Loss 6 6
No Information 5 5
Stroke/CVA 5 5
Necrosis 5 5
Seroma 5 5
Neurological Deficit/Dysfunction 4 4
Anaphylactic Shock 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Insufficient Information 3 3
Vascular Dissection 3 3
Granuloma 3 3
Cerebrospinal Fluid Leakage 3 3
Myocardial Infarction 3 3
Brain Injury 3 3
Thromboembolism 2 2
Fluid Discharge 2 2
Foreign Body In Patient 2 2
Rupture 2 2
Pain 2 2
Aortic Regurgitation 2 2
Abscess 2 2
Bacterial Infection 2 2
Hemorrhage/Bleeding 2 2
Hepatitis 2 2
Ischemia 2 2
Meningitis 2 2
Reaction to Medicinal Component of Device 2 2
Swelling/ Edema 1 1
Cancer 1 1
Pericardial Effusion 1 1
Foreign Body Embolism 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Solid Tumour 1 1
Itching Sensation 1 1
Mitral Regurgitation 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Hematoma 1 1
Foreign Body Reaction 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
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Pulmonary Valve Stenosis 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
No Known Impact Or Consequence To Patient 1 1
Valvular Stenosis 1 1
Coma 1 1
Fungal Infection 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

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