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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway, oropharyngeal, anesthesiology
Product CodeCAE
Regulation Number 868.5110
Device Class 1

MDR Year MDR Reports MDR Events
2019 80 80
2020 30 30
2021 62 62
2022 51 51
2023 52 52
2024 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 55 55
Inflation Problem 33 33
Deflation Problem 24 24
Break 18 18
Leak/Splash 17 17
Material Separation 17 17
Adverse Event Without Identified Device or Use Problem 10 10
Detachment of Device or Device Component 10 10
Deformation Due to Compressive Stress 8 8
Material Split, Cut or Torn 7 7
Material Integrity Problem 6 6
Obstruction of Flow 6 6
Physical Resistance/Sticking 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Damaged Prior to Use 5 5
Appropriate Term/Code Not Available 5 5
Contamination /Decontamination Problem 5 5
Use of Device Problem 5 5
Disconnection 5 5
Material Protrusion/Extrusion 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Material Puncture/Hole 4 4
Fitting Problem 4 4
Structural Problem 4 4
Material Deformation 4 4
Improper or Incorrect Procedure or Method 3 3
Loose or Intermittent Connection 3 3
Difficult to Insert 3 3
Insufficient Information 3 3
Separation Problem 3 3
Device Handling Problem 3 3
Material Rupture 3 3
Nonstandard Device 3 3
Device Dislodged or Dislocated 3 3
Delivered as Unsterile Product 2 2
Infusion or Flow Problem 2 2
Material Too Rigid or Stiff 2 2
Unintended Movement 2 2
Complete Blockage 2 2
Defective Device 2 2
Positioning Problem 2 2
Patient Device Interaction Problem 2 2
Fracture 2 2
Material Fragmentation 2 2
Device Markings/Labelling Problem 2 2
Product Quality Problem 1 1
Difficult or Delayed Positioning 1 1
Incorrect Measurement 1 1
Dent in Material 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 156 156
No Consequences Or Impact To Patient 58 58
No Patient Involvement 24 24
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 15 15
Foreign Body In Patient 6 6
Low Oxygen Saturation 5 5
Cardiac Arrest 3 3
Numbness 3 3
Hypoxia 3 3
Airway Obstruction 3 3
Unintended Extubation 3 3
Cyanosis 2 2
Death 2 2
Hypoventilation 2 2
No Code Available 2 2
Laceration(s) 2 2
Ecchymosis 2 2
Respiratory Insufficiency 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Gastrointestinal Problem 1 1
Respiratory Arrest 1 1
Hematoma 1 1
Obstruction/Occlusion 1 1
Laceration(s) of Esophagus 1 1
Abrasion 1 1
Dysphagia/ Odynophagia 1 1
Bronchospasm 1 1
Pulmonary Edema 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Extubate 1 1
Pressure Sores 1 1
Hemorrhage/Bleeding 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bound Tree Medical II Jul-10-2020
2 Intersurgical Inc II Oct-17-2022
3 King Systems Corp. dba Ambu, Inc. II May-29-2019
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
8 Sarnova HC, Llc II Jan-12-2024
9 SunMed Holdings, LLC II Jan-26-2023
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